A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine
A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared With the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
586
14 countries
209
Brief Summary
This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started Sep 2009
Longer than P75 for phase_3 diabetes-mellitus-type-2
209 active sites
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
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 11, 2009
CompletedFirst Posted
Study publicly available on registry
September 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
July 16, 2014
CompletedJanuary 11, 2017
November 1, 2016
2.1 years
September 11, 2009
May 1, 2014
November 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 26
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 26 minus the value at BL. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (\<65 years versus ≥65 years) as factors and Baseline HbA1c as a continuous covariate.The last observation carried forward (LOCF) method was used to impute missing post-BL 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 26
Secondary Outcomes (7)
Change From Baseline in HbA1c at Weeks 36, 48 and 52
Baseline and Weeks 36, 48 and 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Baseline and Week 26
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 36, 48 and 52
Baseline and Weeks 36, 48 and 52
Number of Participants Who Achieved HbA1c Response Level of <6.5% and <7.0% at Week 26
Week 26
Time to Hyperglycemia Rescue
From the start of study medication until the end of the treatment (up to Week 52)
- +2 more secondary outcomes
Study Arms (2)
albiglutide + insulin glargine
ACTIVE COMPARATORalbiglutide in combination with insulin glargine
insulin glargine + preprandial lispro insulin
ACTIVE COMPARATORinsulin glargine in combination with preprandial lispro insulin
Interventions
albiglutide in combination with insulin glargine
insulin glargine in combination with preprandial lispro insulin
Eligibility Criteria
You may qualify if:
- Subjects with type 2 diabetes, currently treated with insulin glargine or other intermediate- or long-acting insulin, with or without oral antidiabetic medications, but experiencing inadequate glycemic control and willing and capable of participating in a regimen of intensive insulin administration. A subject who has been on an intermediate- or long acting insulin for \>/=6 months but \<5 years, and, in spite of dosage adjustments based on home blood glucose monitoring, is unable to achieve a HbA1c of \<7%.
- BMI \>/= 20kg/m2 and \</=45 kg/m2
- Fasting C-peptide \>/=0.8 ng/mL (\>/= 0.26 nmol/L)
- HbA1c between 7.0% and 10.5%, inclusive
- Use of oral or systemically injected glucocorticoids is generally not allowed within 3 months before randomization; inhaled, intra articular, and topical corticosteroids are allowed
- Hemoglobin \</=11 g/dL for male subjects and \>/=10 g/dL for female subjects
- Creatinine clearance \>60 mL/min (calculated using the Cockcroft Gault formula)
- Thyroid stimulating hormone level is normal or clinically euthyroid as demonstrated by further thyroid tests (e.g., T4, T3, thyroid-binding globulin)
- Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception. Adequate contraception must be practiced for the duration of participation in the study including the 8 week Posttreatment Follow-up Period
- Able and willing to monitor his or her own blood glucose concentrations with a home glucose monitor as per the protocol recommendations of self administration
- No major illness or debility that in the investigator's opinion prohibits the subject from actively participating in their diabetes management and completing the study
- Able and willing to provide written informed consent
You may not qualify if:
- History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 3 years before Screening.
- History of treated diabetic gastroparesis
- Current ongoing symptomatic biliary disease or history of pancreatitis
- History of significant gastrointestinal surgery, including gastric bypass and banding, antrectomy, Roux en Y bypass, gastric vagotomy, small bowel resection, or surgeries thought to significantly affect upper gastrointestinal function
- Recent clinically significant cardiovascular and/or cerebrovascular disease including but not limited to the following:
- Previous history of stroke or transient ischemic attack within 1 month before Screening.
- Acute coronary syndrome, which includes the following:
- Documented MI within the 2 months before Screening and during the period up until receiving the first dose of study medication
- Any cardiac surgery including percutaneous transluminal coronary angioplasty, coronary stent placement, or coronary artery bypass graft surgery within the 2 months before Screening and during the period up until receiving the first dose of study medication
- Unstable angina not responsive to nitroglycerin within the 2 months before Screening and during the period up until receiving the first dose of study medication
- Unstable cardiac rhythm, however, as an example, controlled atrial fibrillation is allowed
- Current or history of heart failure (New York Heart Association class I to IV).
- Resting systolic pressure is \>160 mm Hg and/or diastolic pressure \>100 mm Hg.
- QTc interval (Fridericia) \>470 ms confirmed by a central reader at Screening
- History of stroke or other central nervous system disorder that would negatively impact the subject's ability to participate in a program of intensive insulin management (eg, physically or mentally incapable of performing home blood glucose monitoring or administering and/or adjusting insulin dosage)
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (209)
GSK Investigational Site
Birmingham, Alabama, 35205, United States
GSK Investigational Site
Dothan, Alabama, 36301, United States
GSK Investigational Site
Gilbert, Arizona, 85295, United States
GSK Investigational Site
Phoenix, Arizona, 85028, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Searcy, Arkansas, 72143, United States
GSK Investigational Site
Chino, California, 91710, United States
GSK Investigational Site
Commerce, California, 90040, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Fullerton, California, 92835, United States
GSK Investigational Site
Huntington Beach, California, 92646, United States
GSK Investigational Site
La Jolla, California, 92037, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Los Alamitos, California, 90720, United States
GSK Investigational Site
Los Angeles, California, 90073, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Sacramento, California, 95821, United States
GSK Investigational Site
San Diego, California, 92117, United States
GSK Investigational Site
San Diego, California, 92128, United States
GSK Investigational Site
San Diego, California, 92161, United States
GSK Investigational Site
Satna Monica, California, 90404, United States
GSK Investigational Site
Spring Valley, California, 91978, United States
GSK Investigational Site
Tustin, California, 92780, United States
GSK Investigational Site
Walnut Creek, California, 94598, United States
GSK Investigational Site
West Hills, California, 91307, United States
GSK Investigational Site
Denver, Colorado, 80220, United States
GSK Investigational Site
New Britain, Connecticut, 06050, United States
GSK Investigational Site
Trumbull, Connecticut, 06611, United States
GSK Investigational Site
Waterbury, Connecticut, 06708, United States
GSK Investigational Site
Boynton Beach, Florida, 33437, United States
GSK Investigational Site
Clearwater, Florida, 33756, United States
GSK Investigational Site
Cutler Bay, Florida, 33189, United States
GSK Investigational Site
Hallandale, Florida, 33009, United States
GSK Investigational Site
Jacksonville, Florida, 32205, United States
GSK Investigational Site
Lauderdale Lakes, Florida, 33319, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Orlando, Florida, 32822, United States
GSK Investigational Site
Plantation, Florida, 33317, United States
GSK Investigational Site
West Palm Beach, Florida, 33401, United States
GSK Investigational Site
Atlanta, Georgia, 30308, United States
GSK Investigational Site
Atlanta, Georgia, 30338, United States
GSK Investigational Site
Blue Ridge, Georgia, 30513, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Savannah, Georgia, 31419, United States
GSK Investigational Site
Snellville, Georgia, 30078, United States
GSK Investigational Site
Honolulu, Hawaii, 96813, United States
GSK Investigational Site
Honolulu, Hawaii, 96814, United States
GSK Investigational Site
Idaho Falls, Idaho, 83404, United States
GSK Investigational Site
La Grange, Illinois, 60525, United States
GSK Investigational Site
Avon, Indiana, 46123, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Lafayette, Indiana, 47904, United States
GSK Investigational Site
Council Bluffs, Iowa, 51501, United States
GSK Investigational Site
Des Moines, Iowa, 50314, United States
GSK Investigational Site
Iowa City, Iowa, 52243, United States
GSK Investigational Site
Newton, Kansas, 67114, United States
GSK Investigational Site
Topeka, Kansas, 66606, United States
GSK Investigational Site
Lexington, Kentucky, 40503, United States
GSK Investigational Site
Lexington, Kentucky, 40504, United States
GSK Investigational Site
Shreveport, Louisiana, 71101, United States
GSK Investigational Site
Hyattsville, Maryland, 20782, United States
GSK Investigational Site
Haverhill, Massachusetts, 01830, United States
GSK Investigational Site
Ann Arbor, Michigan, 48106, United States
GSK Investigational Site
Benzonia, Michigan, 49616, United States
GSK Investigational Site
Bloomfield Hills, Michigan, 48302, United States
GSK Investigational Site
Dearborn, Michigan, 48124, United States
GSK Investigational Site
Kalamazoo, Michigan, 49009, United States
GSK Investigational Site
Kalamazoo, Michigan, 49048, United States
GSK Investigational Site
Picayune, Mississippi, 39466, United States
GSK Investigational Site
Chesterfield, Missouri, 63017, United States
GSK Investigational Site
Jefferson City, Missouri, 65109, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Springfield, Missouri, 65807, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Great Falls, Montana, 59405, United States
GSK Investigational Site
Omaha, Nebraska, 68124, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Haddon Heights, New Jersey, 08035, United States
GSK Investigational Site
New York, New York, 10025, United States
GSK Investigational Site
North Massapequa, New York, 11758, United States
GSK Investigational Site
Asheville, North Carolina, 28803, United States
GSK Investigational Site
Burlington, North Carolina, 27215, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Hickory, North Carolina, 28601, United States
GSK Investigational Site
Morehead City, North Carolina, 28557, United States
GSK Investigational Site
Tabor City, North Carolina, 28463, United States
GSK Investigational Site
Akron, Ohio, 44320, United States
GSK Investigational Site
Canal Fulton, Ohio, 44614, United States
GSK Investigational Site
Cincinnati, Ohio, 45245, United States
GSK Investigational Site
Cleveland, Ohio, 44122, United States
GSK Investigational Site
Columbus, Ohio, 43213, United States
GSK Investigational Site
Dayton, Ohio, 45439, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Tulsa, Oklahoma, 74104, United States
GSK Investigational Site
Tulsa, Oklahoma, 74136, United States
GSK Investigational Site
Bensalem, Pennsylvania, 19020, United States
GSK Investigational Site
Carlisle, Pennsylvania, 17013, United States
GSK Investigational Site
Tipton, Pennsylvania, 16684, United States
GSK Investigational Site
Uniontown, Pennsylvania, 15401, United States
GSK Investigational Site
Greenville, South Carolina, 29601, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Murrells Inlet, South Carolina, 29576, United States
GSK Investigational Site
Clarksville, Tennessee, 37043, United States
GSK Investigational Site
Johnson City, Tennessee, 37604, United States
GSK Investigational Site
McKenzie, Tennessee, 38201, United States
GSK Investigational Site
Memphis, Tennessee, 38125, United States
GSK Investigational Site
Tullahoma, Tennessee, 37398, United States
GSK Investigational Site
Arlington, Texas, 76012, United States
GSK Investigational Site
Bedford, Texas, 76201, United States
GSK Investigational Site
Corpus Christi, Texas, 78404, United States
GSK Investigational Site
Dallas, Texas, 75224, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Dallas, Texas, 75251, United States
GSK Investigational Site
El Paso, Texas, 79925, United States
GSK Investigational Site
Houston, Texas, 77024, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77058, United States
GSK Investigational Site
Houston, Texas, 77074, United States
GSK Investigational Site
Katy, Texas, 77450, United States
GSK Investigational Site
Lake Jackson, Texas, 77566, United States
GSK Investigational Site
Midland, Texas, 79707, United States
GSK Investigational Site
North Richland Hills, Texas, 76180, United States
GSK Investigational Site
San Antonio, Texas, 78215, United States
GSK Investigational Site
San Antonio, Texas, 78218, United States
GSK Investigational Site
Schertz, Texas, 78154, United States
GSK Investigational Site
Sugar Land, Texas, 77478, United States
GSK Investigational Site
Temple, Texas, 76508, United States
GSK Investigational Site
Bountiful, Utah, 84010, United States
GSK Investigational Site
Salt Lake City, Utah, 84102, United States
GSK Investigational Site
Salt Lake City, Utah, 84124, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Burke, Virginia, 22015, United States
GSK Investigational Site
Hampton, Virginia, 23666, United States
GSK Investigational Site
Manassas, Virginia, 20110, United States
GSK Investigational Site
Richmond, Virginia, 23294, United States
GSK Investigational Site
Spokane, Washington, 99216, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Lewisburg, West Virginia, 24901, United States
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-170, Brazil
GSK Investigational Site
BrasĂlia, 71625-009, Brazil
GSK Investigational Site
Mogi das Cruzes, 08780 - 090, Brazil
GSK Investigational Site
Armentières, 59280, France
GSK Investigational Site
VĂ©nissieux, 69200, France
GSK Investigational Site
Witten, North Rhine-Westphalia, 58455, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Berlin, State of Berlin, 10115, Germany
GSK Investigational Site
Shatin, Hong Kong
GSK Investigational Site
Bangalore, 560 054, India
GSK Investigational Site
Bangalore, 560043, India
GSK Investigational Site
Bangalore, 560052, India
GSK Investigational Site
Chennai, 600020, India
GSK Investigational Site
Manipal, 576104, India
GSK Investigational Site
Pachuca, Hidalgo, 42086, Mexico
GSK Investigational Site
Puebla City, Puebla, 72190, Mexico
GSK Investigational Site
Mexico City, 03300, Mexico
GSK Investigational Site
Ica, Ica, 11, Peru
GSK Investigational Site
Lima, Lima Province, 01, Peru
GSK Investigational Site
Huacho, Lima region, Peru
GSK Investigational Site
Piura, Piura, Peru
GSK Investigational Site
Trujillo, Peru
GSK Investigational Site
Marikina City, 1810, Philippines
GSK Investigational Site
Pasay, 1300, Philippines
GSK Investigational Site
Pasig, 1600, Philippines
GSK Investigational Site
Quezon City, 1102, Philippines
GSK Investigational Site
San Juan City, 1500, Philippines
GSK Investigational Site
Tagbilaran City, 6300, Philippines
GSK Investigational Site
Taytay Rizal, 1920, Philippines
GSK Investigational Site
Port Elizabeth, Eastern Cape, 6014, South Africa
GSK Investigational Site
Boksburg North, Gauteng, 1459, South Africa
GSK Investigational Site
Johannesburg, Gauteng, 01820, South Africa
GSK Investigational Site
Johannesburg, Gauteng, 2013, South Africa
GSK Investigational Site
Johannesburg, Gauteng, 2193, South Africa
GSK Investigational Site
Lenasia, Gauteng, 1827, South Africa
GSK Investigational Site
Pretoria, Gauteng, 00083, South Africa
GSK Investigational Site
Durban, KwaZulu-Natal, 4000, South Africa
GSK Investigational Site
Durban, KwaZulu-Natal, 4068, South Africa
GSK Investigational Site
Bellville, 7530, South Africa
GSK Investigational Site
Cape Town, 7530, South Africa
GSK Investigational Site
Kempton Park, 1619, South Africa
GSK Investigational Site
Parow, 7505, South Africa
GSK Investigational Site
Somerset West, 7130, South Africa
GSK Investigational Site
Goyang-si, 411706, South Korea
GSK Investigational Site
Koyang-shi, 411710, South Korea
GSK Investigational Site
Seongnam-si, 463-707, South Korea
GSK Investigational Site
Seongnam-si, 463712, South Korea
GSK Investigational Site
Seoul, 135-720, South Korea
GSK Investigational Site
Seoul, 137-701, South Korea
GSK Investigational Site
Seoul, 139-872, South Korea
GSK Investigational Site
Suwon, Kyonggi-do, 443-721, South Korea
GSK Investigational Site
Alzira, 46600, Spain
GSK Investigational Site
Barcelona, 08022, Spain
GSK Investigational Site
Madrid, 28034, Spain
GSK Investigational Site
Palma de Mallorca, 07010, Spain
GSK Investigational Site
Sabadell, 08208, Spain
GSK Investigational Site
Seville, 41003, Spain
GSK Investigational Site
Taichung, 404, Taiwan
GSK Investigational Site
Tainan, 71044, Taiwan
GSK Investigational Site
Taipei, 100, Taiwan
GSK Investigational Site
Taipei, 11490, Taiwan
GSK Investigational Site
Taipei County, 23137, Taiwan
GSK Investigational Site
Liverpool, Merseyside, L7 8XP, United Kingdom
GSK Investigational Site
Hull, HU3 2RW, United Kingdom
GSK Investigational Site
London, SE 1 9RT, United Kingdom
GSK Investigational Site
Plymouth, PL6 8BX, United Kingdom
Related Publications (1)
Rosenstock J, Fonseca VA, Gross JL, Ratner RE, Ahren B, Chow FC, Yang F, Miller D, Johnson SL, Stewart MW, Leiter LA; Harmony 6 Study Group. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care. 2014 Aug;37(8):2317-25. doi: 10.2337/dc14-0001. Epub 2014 Jun 4.
PMID: 24898300DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2009
First Posted
September 14, 2009
Study Start
September 1, 2009
Primary Completion
October 1, 2011
Study Completion
May 1, 2012
Last Updated
January 11, 2017
Results First Posted
July 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.