NCT00838903

Brief Summary

The purpose of this study is to determine if albiglutide is safe and effective in the treatment of type 2 diabetes.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,049

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
11 countries

386 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 16, 2014

Completed
Last Updated

January 9, 2017

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

February 5, 2009

Results QC Date

April 17, 2014

Last Update Submit

November 18, 2016

Conditions

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.

    Baseline and Week 104

Secondary Outcomes (8)

  • Change From Baseline in HbA1c at Week 156

    Baseline and Week 156

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104

    Baseline and Week 104

  • Change From Baseline in FPG at Week 156

    Baseline and Week 156

  • Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 104

    Week 104

  • Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156

    Week 156

  • +3 more secondary outcomes

Study Arms (4)

albiglutide + metformin

EXPERIMENTAL

Albiglutide + metformin + placebo sitagliptin + placebo glimepiride

Biological: albiglutideDrug: metforminDrug: placebo sitagliptinDrug: placebo glimepiride

sitagliptin + metformin

ACTIVE COMPARATOR

Sitagliptin + metformin + placebo albiglutide + placebo glimepiride

Drug: sitagliptinDrug: metforminBiological: placebo albiglutideDrug: placebo glimepiride

glimepiride + metformin

ACTIVE COMPARATOR

Glimepiride + metformin + placebo albiglutide + placebo sitagliptin

Drug: glimepirideDrug: metforminBiological: placebo albiglutideDrug: placebo sitagliptin

metformin + placebo

ACTIVE COMPARATOR

Metformin + placebo albiglutide + placebo sitagliptin + placebo glimepiride

Drug: metforminBiological: placebo albiglutideDrug: placebo sitagliptinDrug: placebo glimepiride

Interventions

albiglutideBIOLOGICAL

albiglutide

albiglutide + metformin

sitagliptin

sitagliptin + metformin

Glimepiride

glimepiride + metformin

Metformin

albiglutide + metforminglimepiride + metforminmetformin + placebositagliptin + metformin

placebo to match albiglutide

glimepiride + metforminmetformin + placebositagliptin + metformin

placebo to match sitagliptin

albiglutide + metforminglimepiride + metforminmetformin + placebo

placebo to match glimepiride

albiglutide + metforminmetformin + placebositagliptin + metformin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes
  • BMI 20-45kg/m2 inclusive

You may not qualify if:

  • females who are pregnant, lactating or \<6 weeks post-partum
  • current symptomatic heart failure (NYHA Class III or IV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (386)

GSK Investigational Site

Birmingham, Alabama, 35235, United States

Location

GSK Investigational Site

Birmingham, Alabama, 35242, United States

Location

GSK Investigational Site

Dothan, Alabama, 36301, United States

Location

GSK Investigational Site

Hueytown, Alabama, 35023, United States

Location

GSK Investigational Site

Mobile, Alabama, 36617, United States

Location

GSK Investigational Site

Tuscaloosa, Alabama, 35406, United States

Location

GSK Investigational Site

Chandler, Arizona, 85224, United States

Location

GSK Investigational Site

Gilbert, Arizona, 85295, United States

Location

GSK Investigational Site

Green Valley, Arizona, 85614, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85023, United States

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GSK Investigational Site

Phoenix, Arizona, 85028, United States

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GSK Investigational Site

Phoenix, Arizona, 85051, United States

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GSK Investigational Site

Tucson, Arizona, 85712, United States

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GSK Investigational Site

Tucson, Arizona, 85745, United States

Location

GSK Investigational Site

Bull Shoals, Arkansas, 72619, United States

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GSK Investigational Site

Harrisburg, Arkansas, 72432, United States

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GSK Investigational Site

Hot Springs, Arkansas, 71913, United States

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GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

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GSK Investigational Site

Searcy, Arkansas, 72143, United States

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GSK Investigational Site

Buena Park, California, 90620, United States

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GSK Investigational Site

Carmichael, California, 95608, United States

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GSK Investigational Site

Chino, California, 91710, United States

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GSK Investigational Site

Chula Vista, California, 91910, United States

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GSK Investigational Site

Escondido, California, 92026, United States

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GSK Investigational Site

Foothill Ranch, California, 92610, United States

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GSK Investigational Site

Fountain Valley, California, 92708, United States

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GSK Investigational Site

Fresno, California, 93720, United States

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GSK Investigational Site

Huntington Beach, California, 92646, United States

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GSK Investigational Site

Indio, California, 92201, United States

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GSK Investigational Site

La Jolla, California, 92037, United States

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GSK Investigational Site

Lakewood, California, 90712, United States

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GSK Investigational Site

Loma Linda, California, 92354, United States

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GSK Investigational Site

Long Beach, California, 90806, United States

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GSK Investigational Site

Los Alamitos, California, 90720, United States

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GSK Investigational Site

Los Angeles, California, 90017, United States

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GSK Investigational Site

Los Angeles, California, 90022, United States

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GSK Investigational Site

Los Angeles, California, 90025, United States

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GSK Investigational Site

Mission Viejo, California, 92691, United States

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GSK Investigational Site

Northridge, California, 91325, United States

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GSK Investigational Site

Palm Desert, California, 92260, United States

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GSK Investigational Site

Pasadena, California, 91105, United States

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GSK Investigational Site

Poway, California, 92064, United States

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Riverside, California, 92506, United States

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GSK Investigational Site

Sacramento, California, 95821, United States

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GSK Investigational Site

Sacramento, California, 95825, United States

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GSK Investigational Site

San Diego, California, 92117, United States

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GSK Investigational Site

San Diego, California, 92120, United States

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GSK Investigational Site

Santa Ana, California, 92701, United States

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GSK Investigational Site

Satna Monica, California, 90404, United States

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GSK Investigational Site

Spring Valley, California, 91978, United States

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GSK Investigational Site

Tarzana, California, 91356, United States

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GSK Investigational Site

Victorville, California, 92395, United States

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GSK Investigational Site

Vista, California, 92083, United States

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GSK Investigational Site

Walnut Creek, California, 94598, United States

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GSK Investigational Site

West Hills, California, 91307, United States

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GSK Investigational Site

Arvada, Colorado, 80005, United States

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GSK Investigational Site

New Britain, Connecticut, 06050, United States

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GSK Investigational Site

Trumbull, Connecticut, 06611, United States

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GSK Investigational Site

Waterbury, Connecticut, 06708, United States

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GSK Investigational Site

Middletown, Delaware, 19709, United States

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Boynton Beach, Florida, 33426, United States

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GSK Investigational Site

Boynton Beach, Florida, 33437, United States

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GSK Investigational Site

Clearwater, Florida, 33756, United States

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GSK Investigational Site

Clearwater, Florida, 33765, United States

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GSK Investigational Site

Cocoa, Florida, 32927, United States

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GSK Investigational Site

Cutler Bay, Florida, 33189, United States

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GSK Investigational Site

Deerfield Beach, Florida, 33442, United States

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Delray Beach, Florida, 33445, United States

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GSK Investigational Site

Fort Lauderdale, Florida, 33316, United States

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GSK Investigational Site

Gainesville, Florida, 32605, United States

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GSK Investigational Site

Hallandale, Florida, 33009, United States

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GSK Investigational Site

Hialeah, Florida, 33012, United States

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GSK Investigational Site

Hialeah, Florida, 33013, United States

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GSK Investigational Site

Hollywood, Florida, 33023, United States

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GSK Investigational Site

Lauderdale Lakes, Florida, 33319, United States

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GSK Investigational Site

Marianna, Florida, 32446, United States

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GSK Investigational Site

Miami, Florida, 33135, United States

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GSK Investigational Site

Miami, Florida, 33156, United States

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GSK Investigational Site

North Miami, Florida, 33161, United States

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GSK Investigational Site

Ocala, Florida, 34471, United States

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GSK Investigational Site

Orlando, Florida, 32822, United States

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GSK Investigational Site

Ormond Beach, Florida, 32174, United States

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GSK Investigational Site

Oviedo, Florida, 32765, United States

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GSK Investigational Site

Panama City, Florida, 32401, United States

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GSK Investigational Site

Pembroke Pines, Florida, 33026, United States

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GSK Investigational Site

Pembroke Pines, Florida, 33027, United States

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GSK Investigational Site

Plantation, Florida, 33317, United States

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GSK Investigational Site

Ponte Vedra Beach, Florida, 32081, United States

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GSK Investigational Site

Saint Cloud, Florida, 34769, United States

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GSK Investigational Site

St. Petersburg, Florida, 33709, United States

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GSK Investigational Site

Tampa, Florida, 33603, United States

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GSK Investigational Site

West Palm Beach, Florida, 33401, United States

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GSK Investigational Site

Atlanta, Georgia, 30135, United States

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GSK Investigational Site

Atlanta, Georgia, 30308, United States

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GSK Investigational Site

Atlanta, Georgia, 30312, United States

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GSK Investigational Site

Atlanta, Georgia, 30328, United States

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GSK Investigational Site

Atlanta, Georgia, 30342, United States

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GSK Investigational Site

Blue Ridge, Georgia, 30513, United States

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GSK Investigational Site

Columbus, Georgia, 31904, United States

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GSK Investigational Site

Decatur, Georgia, 30032, United States

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GSK Investigational Site

Savannah, Georgia, 31406, United States

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GSK Investigational Site

Snellville, Georgia, 30078, United States

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GSK Investigational Site

Stone Mountain, Georgia, 30088, United States

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GSK Investigational Site

Tucker, Georgia, 30084, United States

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GSK Investigational Site

Honolulu, Hawaii, 96813, United States

Location

GSK Investigational Site

Honolulu, Hawaii, 96814, United States

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GSK Investigational Site

Idaho Falls, Idaho, 83404, United States

Location

GSK Investigational Site

Aurora, Illinois, 60504, United States

Location

GSK Investigational Site

Chicago, Illinois, 60607, United States

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GSK Investigational Site

Evergreen Park, Illinois, 60805, United States

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GSK Investigational Site

La Grange, Illinois, 60525, United States

Location

GSK Investigational Site

Naperville, Illinois, 60564, United States

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GSK Investigational Site

Peoria, Illinois, 61602, United States

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GSK Investigational Site

Fishers, Indiana, 46037, United States

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GSK Investigational Site

Indianapolis, Indiana, 46254, United States

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GSK Investigational Site

La Porte, Indiana, 46350, United States

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GSK Investigational Site

Muncie, Indiana, 47304, United States

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GSK Investigational Site

South Bend, Indiana, 46614, United States

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GSK Investigational Site

Council Bluffs, Iowa, 51501, United States

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GSK Investigational Site

Des Moines, Iowa, 50314, United States

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GSK Investigational Site

Dubuque, Iowa, 52001, United States

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GSK Investigational Site

Iowa City, Iowa, 52243, United States

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GSK Investigational Site

Waterloo, Iowa, 50701, United States

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GSK Investigational Site

Arkansas City, Kansas, 67005, United States

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GSK Investigational Site

Mission, Kansas, 66202, United States

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GSK Investigational Site

Newton, Kansas, 67114, United States

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GSK Investigational Site

Overland Park, Kansas, 66211, United States

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GSK Investigational Site

Topeka, Kansas, 66606, United States

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GSK Investigational Site

Wichita, Kansas, 67211, United States

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GSK Investigational Site

Crescent Springs, Kentucky, 41017, United States

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GSK Investigational Site

Lexington, Kentucky, 40503, United States

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GSK Investigational Site

Lexington, Kentucky, 40504, United States

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GSK Investigational Site

Louisville, Kentucky, 40202, United States

Location

GSK Investigational Site

Madisonville, Kentucky, 42431, United States

Location

GSK Investigational Site

Paducah, Kentucky, 42003, United States

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GSK Investigational Site

Covington, Louisiana, 70433, United States

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GSK Investigational Site

Lake Charles, Louisiana, 70601, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71101, United States

Location

GSK Investigational Site

Shreveport, Louisiana, 71115, United States

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GSK Investigational Site

Baltimore, Maryland, 21237, United States

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GSK Investigational Site

Hyattsville, Maryland, 20782, United States

Location

GSK Investigational Site

Oxon Hill, Maryland, 20745, United States

Location

GSK Investigational Site

Haverhill, Massachusetts, 01830, United States

Location

GSK Investigational Site

Bay City, Michigan, 48706, United States

Location

GSK Investigational Site

Benzonia, Michigan, 49616, United States

Location

GSK Investigational Site

Cadillac, Michigan, 49601, United States

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GSK Investigational Site

Dearborn, Michigan, 48124, United States

Location

GSK Investigational Site

Interlochen, Michigan, 49643, United States

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GSK Investigational Site

Kalamazoo, Michigan, 49009, United States

Location

GSK Investigational Site

Kalamazoo, Michigan, 49048, United States

Location

GSK Investigational Site

Saint Clair Shores, Michigan, 48081, United States

Location

GSK Investigational Site

Gulfport, Mississippi, 39501, United States

Location

GSK Investigational Site

Picayune, Mississippi, 39466, United States

Location

GSK Investigational Site

Rolling Fork, Mississippi, 39159, United States

Location

GSK Investigational Site

Chesterfield, Missouri, 63017, United States

Location

GSK Investigational Site

Jefferson City, Missouri, 65109, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64106, United States

Location

GSK Investigational Site

Kansas City, Missouri, United States

Location

GSK Investigational Site

Springfield, Missouri, 65807, United States

Location

GSK Investigational Site

St Louis, Missouri, 63117, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

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GSK Investigational Site

West Plains, Missouri, 65775, United States

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GSK Investigational Site

Billings, Montana, 59102, United States

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GSK Investigational Site

Butte, Montana, 59701, United States

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GSK Investigational Site

Great Falls, Montana, 59405, United States

Location

GSK Investigational Site

Broken Bow, Nebraska, 68822, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68516, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68124, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68131, United States

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GSK Investigational Site

Omaha, Nebraska, 68134, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89102-4509, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89102, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89103, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89106, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89128, United States

Location

GSK Investigational Site

Berlin, New Jersey, 08009, United States

Location

GSK Investigational Site

Elizabeth, New Jersey, 07202, United States

Location

GSK Investigational Site

Haddon Heights, New Jersey, 08035, United States

Location

GSK Investigational Site

Hainesport, New Jersey, 08036, United States

Location

GSK Investigational Site

New Brunswick, New Jersey, 08903, United States

Location

GSK Investigational Site

Stratford, New Jersey, 08084, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87106, United States

Location

GSK Investigational Site

New York, New York, 10022, United States

Location

GSK Investigational Site

North Massapequa, New York, 11758, United States

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GSK Investigational Site

Syracuse, New York, 13210, United States

Location

GSK Investigational Site

Asheboro, North Carolina, 27203, United States

Location

GSK Investigational Site

Asheville, North Carolina, 28803, United States

Location

GSK Investigational Site

Burlington, North Carolina, 27215, United States

Location

GSK Investigational Site

Calabash, North Carolina, 28467, United States

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GSK Investigational Site

Chadbourn, North Carolina, 28431, United States

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GSK Investigational Site

Durham, North Carolina, 27710, United States

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GSK Investigational Site

Fayetteville, North Carolina, 28304, United States

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GSK Investigational Site

Greensboro, North Carolina, 27405, United States

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GSK Investigational Site

Hickory, North Carolina, 28601, United States

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GSK Investigational Site

Huntersville, North Carolina, 28078, United States

Location

GSK Investigational Site

Lenoir, North Carolina, 28645, United States

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GSK Investigational Site

Mint Hill, North Carolina, 28227, United States

Location

GSK Investigational Site

Morehead City, North Carolina, 28557, United States

Location

GSK Investigational Site

Shelby, North Carolina, 28150, United States

Location

GSK Investigational Site

Tabor City, North Carolina, 28463, United States

Location

GSK Investigational Site

Grand Forks, North Dakota, 58201, United States

Location

GSK Investigational Site

Akron, Ohio, 44320, United States

Location

GSK Investigational Site

Canal Fulton, Ohio, 44614, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45211, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45219, United States

Location

GSK Investigational Site

Cincinnati, Ohio, 45227, United States

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GSK Investigational Site

Cincinnati, Ohio, 45245, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44122, United States

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GSK Investigational Site

Columbus, Ohio, 43212, United States

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GSK Investigational Site

Columbus, Ohio, 43213, United States

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GSK Investigational Site

Dayton, Ohio, 45432, United States

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GSK Investigational Site

Dayton, Ohio, 45439, United States

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GSK Investigational Site

Kettering, Ohio, 45429, United States

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GSK Investigational Site

Mason, Ohio, 45040, United States

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GSK Investigational Site

Maumee, Ohio, 43537-9402, United States

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Thornville, Ohio, 43076, United States

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GSK Investigational Site

Zanesville, Ohio, 43701, United States

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Oklahoma City, Oklahoma, 73103, United States

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GSK Investigational Site

Tulsa, Oklahoma, 74104, United States

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GSK Investigational Site

Tulsa, Oklahoma, 74135, United States

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GSK Investigational Site

Tulsa, Oklahoma, 74136, United States

Location

GSK Investigational Site

Ashland, Oregon, 97520, United States

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GSK Investigational Site

Bensalem, Pennsylvania, 19020, United States

Location

GSK Investigational Site

Carlisle, Pennsylvania, 17013, United States

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GSK Investigational Site

Downington, Pennsylvania, 19335, United States

Location

GSK Investigational Site

Feasterville, Pennsylvania, 19053, United States

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GSK Investigational Site

Harrisburg, Pennsylvania, 17112, United States

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GSK Investigational Site

Landsdale, Pennsylvania, 19446, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15243, United States

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GSK Investigational Site

Tipton, Pennsylvania, 16684, United States

Location

GSK Investigational Site

Uniontown, Pennsylvania, 15401, United States

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GSK Investigational Site

Cumberland, Rhode Island, 02864, United States

Location

GSK Investigational Site

East Providence, Rhode Island, 02914, United States

Location

GSK Investigational Site

Columbia, South Carolina, 29201, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29601, United States

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GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Greer, South Carolina, 29651, United States

Location

GSK Investigational Site

Manning, South Carolina, 29102, United States

Location

GSK Investigational Site

Murrells Inlet, South Carolina, 29576, United States

Location

GSK Investigational Site

North Myrtle Beach, South Carolina, 29582, United States

Location

GSK Investigational Site

Orangeburg, South Carolina, 29115, United States

Location

GSK Investigational Site

Simpsonville, South Carolina, 29681, United States

Location

GSK Investigational Site

Taylors, South Carolina, 29687, United States

Location

GSK Investigational Site

Bristol, Tennessee, 37620, United States

Location

GSK Investigational Site

Chattanooga, Tennessee, 37421, United States

Location

GSK Investigational Site

Clarksville, Tennessee, 37043, United States

Location

GSK Investigational Site

Columbia, Tennessee, 38401, United States

Location

GSK Investigational Site

Fayetteville, Tennessee, 37334, United States

Location

GSK Investigational Site

Germantown, Tennessee, 38138, United States

Location

GSK Investigational Site

Johnson City, Tennessee, 37604, United States

Location

GSK Investigational Site

McKenzie, Tennessee, 38201, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38125, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37203, United States

Location

GSK Investigational Site

Tullahoma, Tennessee, 37398, United States

Location

GSK Investigational Site

Arlington, Texas, 76012, United States

Location

GSK Investigational Site

Bedford, Texas, 76201, United States

Location

GSK Investigational Site

Cleburne, Texas, 76033, United States

Location

GSK Investigational Site

Corpus Christi, Texas, 78414, United States

Location

GSK Investigational Site

Dallas, Texas, 75224, United States

Location

GSK Investigational Site

Dallas, Texas, 75230, United States

Location

GSK Investigational Site

Dallas, Texas, 75235, United States

Location

GSK Investigational Site

Deer Park, Texas, 77536, United States

Location

GSK Investigational Site

El Paso, Texas, 79925, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76135, United States

Location

GSK Investigational Site

Houston, Texas, 77024, United States

Location

GSK Investigational Site

Houston, Texas, 77027, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

Houston, Texas, 77034, United States

Location

GSK Investigational Site

Houston, Texas, 77036, United States

Location

GSK Investigational Site

Houston, Texas, 77055, United States

Location

GSK Investigational Site

Houston, Texas, 77058, United States

Location

GSK Investigational Site

Houston, Texas, 77069, United States

Location

GSK Investigational Site

Houston, Texas, 77070, United States

Location

GSK Investigational Site

Houston, Texas, 77074, United States

Location

GSK Investigational Site

Houston, Texas, 77094, United States

Location

GSK Investigational Site

Hurst, Texas, 76054, United States

Location

GSK Investigational Site

Katy, Texas, 77450, United States

Location

GSK Investigational Site

Lake Jackson, Texas, 77566, United States

Location

GSK Investigational Site

Lewisville, Texas, 75067, United States

Location

GSK Investigational Site

Midland, Texas, 79707, United States

Location

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North Richland Hills, Texas, 76180, United States

Location

GSK Investigational Site

Odessa, Texas, 79761, United States

Location

GSK Investigational Site

San Antonio, Texas, 78205, United States

Location

GSK Investigational Site

San Antonio, Texas, 78215, United States

Location

GSK Investigational Site

San Antonio, Texas, 78217, United States

Location

GSK Investigational Site

San Antonio, Texas, 78218, United States

Location

GSK Investigational Site

San Antonio, Texas, 78224, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

San Antonio, Texas, 78237, United States

Location

GSK Investigational Site

San Antonio, Texas, 78258, United States

Location

GSK Investigational Site

Schertz, Texas, 78154, United States

Location

GSK Investigational Site

Sugar Land, Texas, 77479, United States

Location

GSK Investigational Site

Sugarland, Texas, 77479, United States

Location

GSK Investigational Site

Temple, Texas, 76508, United States

Location

GSK Investigational Site

Bountiful, Utah, 84010, United States

Location

GSK Investigational Site

Orem, Utah, 84058, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84102, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84107, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84124, United States

Location

GSK Investigational Site

West Jordan, Utah, 84088, United States

Location

GSK Investigational Site

West Valley City, Utah, 84120, United States

Location

GSK Investigational Site

South Burlington, Vermont, 05403, United States

Location

GSK Investigational Site

Burke, Virginia, 22015, United States

Location

GSK Investigational Site

Hampton, Virginia, 23666, United States

Location

GSK Investigational Site

Manassas, Virginia, 20110, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23502, United States

Location

GSK Investigational Site

Suffolk, Virginia, United States

Location

GSK Investigational Site

Virgina Beach, Virginia, 23455, United States

Location

GSK Investigational Site

Weber City, Virginia, 24290, United States

Location

GSK Investigational Site

Federal Way, Washington, 98003, United States

Location

GSK Investigational Site

Richland, Washington, 99352, United States

Location

GSK Investigational Site

Selah, Washington, 98942, United States

Location

GSK Investigational Site

Spokane, Washington, 99208, United States

Location

GSK Investigational Site

Spokane, Washington, 99216, United States

Location

GSK Investigational Site

Lewisburg, West Virginia, 24901, United States

Location

GSK Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

GSK Investigational Site

Alabaster, 35007, Albania

Location

GSK Investigational Site

Villingen-Schwenningen, Baden-Wurttemberg, 78054, Germany

Location

GSK Investigational Site

Kelkheim, Hesse, 65779, Germany

Location

GSK Investigational Site

Rotenburg an der Fulda, Hesse, 36199, Germany

Location

GSK Investigational Site

Bad Lauterberg im Harz, Lower Saxony, 37431, Germany

Location

GSK Investigational Site

Witten, North Rhine-Westphalia, 58455, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55116, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10115, Germany

Location

GSK Investigational Site

Kwun Tong, Kowloon, Hong Kong

Location

GSK Investigational Site

Shatin, Hong Kong

Location

GSK Investigational Site

Tai Po, Hong Kong

Location

GSK Investigational Site

Tijuana, Baja California Norte, 22010, Mexico

Location

GSK Investigational Site

TorreĂ³n, Coahuila, 27000, Mexico

Location

GSK Investigational Site

Durango, Durango, 34080, Mexico

Location

GSK Investigational Site

Pachuca, Hidalgo, 42086, Mexico

Location

GSK Investigational Site

Guadalajara, Jalisco, 44670, Mexico

Location

GSK Investigational Site

Zapopan, Jalisco, 45200, Mexico

Location

GSK Investigational Site

Morelia, MichoacĂ¡n, C.P. 58249, Mexico

Location

GSK Investigational Site

Cuernavaca, Morelos, 62250, Mexico

Location

GSK Investigational Site

Puebla City, Puebla, 72190, Mexico

Location

GSK Investigational Site

MĂ©rida, YucatĂ¡n, 97000, Mexico

Location

GSK Investigational Site

Distrito Federal, 06700, Mexico

Location

GSK Investigational Site

Guadalajara, 44600, Mexico

Location

GSK Investigational Site

Guadalajara, 44680, Mexico

Location

GSK Investigational Site

Mexico City, 03300, Mexico

Location

GSK Investigational Site

Mexico City, 11570, Mexico

Location

GSK Investigational Site

NezahualcĂ³yotl, 57170, Mexico

Location

GSK Investigational Site

Ica, Ica, 11, Peru

Location

GSK Investigational Site

Lima, Lima Province, 01, Peru

Location

GSK Investigational Site

Lima, Lima Province, Lima 1, Peru

Location

GSK Investigational Site

Callao, Lima, Callao 2, Peru

Location

GSK Investigational Site

Piura, Piura, Peru

Location

GSK Investigational Site

Cebu City, 6000, Philippines

Location

GSK Investigational Site

Quezon City, 1101, Philippines

Location

GSK Investigational Site

Quezon City, 1102, Philippines

Location

GSK Investigational Site

San Juan City, 1500, Philippines

Location

GSK Investigational Site

Taytay Rizal, 1920, Philippines

Location

GSK Investigational Site

Arkhangelsk, 163045, Russia

Location

GSK Investigational Site

Irkutsk, 664003, Russia

Location

GSK Investigational Site

Moscow, 119034, Russia

Location

GSK Investigational Site

Nizhny Novgorod, 603126, Russia

Location

GSK Investigational Site

Saratov, 410030, Russia

Location

GSK Investigational Site

Smolensk, 214019, Russia

Location

GSK Investigational Site

Yaroslavl, 150062, Russia

Location

GSK Investigational Site

Port Elizabeth, Eastern Cape, 6014, South Africa

Location

GSK Investigational Site

Boksburg North, Gauteng, 1459, South Africa

Location

GSK Investigational Site

Johannesburg, Gauteng, 01820, South Africa

Location

GSK Investigational Site

Lenasia, Gauteng, 1827, South Africa

Location

GSK Investigational Site

Parktown, Gauteng, 2193, South Africa

Location

GSK Investigational Site

Pretoria, Gauteng, 00083, South Africa

Location

GSK Investigational Site

Durban, KwaZulu-Natal, 4000, South Africa

Location

GSK Investigational Site

Cape Town, 7530, South Africa

Location

GSK Investigational Site

Kempton Park, 1619, South Africa

Location

GSK Investigational Site

Parow, 7505, South Africa

Location

GSK Investigational Site

Somerset West, 07129, South Africa

Location

GSK Investigational Site

Soweto, 1111, South Africa

Location

GSK Investigational Site

Barcelona, 08022, Spain

Location

GSK Investigational Site

Seville, 41003, Spain

Location

GSK Investigational Site

Plymouth, Devon, PL6 8BX, United Kingdom

Location

GSK Investigational Site

Canterbury, Kent, CT1 3HX, United Kingdom

Location

GSK Investigational Site

Blackpool, Lancashire, FY4 3AD, United Kingdom

Location

GSK Investigational Site

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

GSK Investigational Site

Sunbury-on-Thames, Middlesex, TW16 6RH, United Kingdom

Location

GSK Investigational Site

Port Glasgow, Renfrewshire, PA14 6HW, United Kingdom

Location

GSK Investigational Site

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

GSK Investigational Site

Glasgow, G45 9AW, United Kingdom

Location

GSK Investigational Site

Hull, HU3 2RW, United Kingdom

Location

GSK Investigational Site

Liverpool, L9 7AL, United Kingdom

Location

GSK Investigational Site

London, SE1 9NH, United Kingdom

Location

Related Publications (1)

  • Home PD, Ahren B, Reusch JEB, Rendell M, Weissman PN, Cirkel DT, Miller D, Ambery P, Carr MC, Nauck MA. Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

rGLP-1 proteinSitagliptin PhosphateglimepirideMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesBiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 9, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2012

Study Completion

April 1, 2013

Last Updated

January 9, 2017

Results First Posted

May 16, 2014

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Available IPD Datasets

Clinical Study Report (112753)Access
Dataset Specification (112753)Access
Study Protocol (112753)Access
Informed Consent Form (112753)Access
Annotated Case Report Form (112753)Access
Statistical Analysis Plan (112753)Access
Individual Participant Data Set (112753)Access

Locations