Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone

NCT00970424 | Terminated Phase 3

• 1 other identifier: DUT-MD-304
• Study Type: interventional
• Target: 252
• Locations: 6 countries
• Sites: 118

Brief Summary

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c Level (HbA1c)

  HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26)

Secondary Outcomes (1)

• Fasting Plasma Glucose Level (FPG)

  FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26).

Study Arms (2)

1

PLACEBO COMPARATOR

placebo, oral tablet administered once daily on background of pioglitazone

Drug: Placebo

2

EXPERIMENTAL

dutogliptin, oral tablet administered once daily on background of pioglitazone

Drug: Dutogliptin

Interventions

Placebo DRUG

placebo, oral tablet administered once daily on background of pioglitazone

1

Dutogliptin DRUG

dutogliptin, oral tablet administered once daily on background of pioglitazone

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)
• BMI 20 to 48 kg/m2, inclusive
• HbA1c 7.0% - 10.0%, inclusive
• Age 18 to 85 years, inclusive

You may not qualify if:

• Currently taking more than one oral hypoglycemic agent
• Type 1 diabetes mellitus

Sponsors & Collaborators

• Forest Laboratories: lead
• Phenomix: collaborator

Study Sites (118)

Forest Investigative Site 064

Birmingham, Alabama, 35205, United States

Location

Forest Investigative Site 020

Birmingham, Alabama, 35235, United States

Location

Forest Investigative Site 059

Chandler, Arizona, 85225, United States

Location

Forest Investigative Site 096

Litchfield, Arizona, 85340, United States

Location

Forest Investigative Site 098

Phoenix, Arizona, 85020, United States

Location

Forest Investigative Site 044

Scottsdale, Arizona, 85254, United States

Location

Forest Investigative Site 087

Tucson, Arizona, 85741, United States

Location

Forest Investigative Site 061

Anaheim, California, 92801, United States

Location

Forest Investigative Site 041

Chula Vista, California, 91911, United States

Location

Forest Investigative Site 049

Encinitas, California, 92024, United States

Location

Forest Investigative Site 022

Greenbrae, California, 94904, United States

Location

Forest Investigative Site 047

Harbor City, California, 90710, United States

Location

Forest Investigative Site 010

Huntington Park, California, 90255, United States

Location

Forest Investigative Site 111

Northridge, California, 91325, United States

Location

Forest Investigative Site 031

Riverside, California, 92506, United States

Location

Forest Investigative Site 091

Roseville, California, 95661, United States

Location

Forest Investigative Site 067

Sacramento, California, 95821, United States

Location

Forest Investigative Site 112

Santa Ana, California, 92701, United States

Location

Forest Investigative Site 011

Walnut Creek, California, 94598, United States

Location

Forest Investigative Site 063

West Hills, California, 91307, United States

Location

Forest Investigative Site 115

Colorado Springs, Colorado, 80910, United States

Location

Forest Investigative Site 073

Clearwater, Florida, 33765, United States

Location

Forest Investigative Site 004

Daytona Beach, Florida, 32117, United States

Location

Forest Investigative Site 052

DeLand, Florida, 32720, United States

Location

Forest Investigative Site 062

Jacksonville, Florida, 32205, United States

Location

Forest Investigative Site 021

Miami, Florida, 33169, United States

Location

Forest Investigative Site 050

Miami, Florida, 33183, United States

Location

Forest Investigative Site 122

Miami, Florida, 33186, United States

Location

Forest Investigative Site 015

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 018

Sarasota, Florida, 34239, United States

Location

Forest Investigative Site 075

St. Petersburg, Florida, 33716, United States

Location

Forest Investigative Site 026

West Palm Beach, Florida, 33401, United States

Location

Forest Investigative Site 045

Atlanta, Georgia, 30338, United States

Location

Forest Investigative Site 079

Augusta, Georgia, 30909, United States

Location

Forest Investigative Site 009

Meridian, Idaho, 83646, United States

Location

Forest Investigative Site 60

Melrose Park, Illinois, 60160, United States

Location

Forest Investigative Site 030

Peoria, Illinois, 61614, United States

Location

Forest Investigative Site 100

Evansville, Indiana, 47710, United States

Location

Forest Investigative Site 097

Evansville, Indiana, 47713, United States

Location

Forest Investigative Site 053

Kansas City, Kansas, 66160, United States

Location

Forest Investigative Site 008

Wichita, Kansas, 67203, United States

Location

Forest Investigative Site 078

Erlanger, Kentucky, 41018, United States

Location

Forest Investigative Site 024

Madisonville, Kentucky, 42431, United States

Location

Forest Investigative Site 034

Covington, Louisiana, 70433, United States

Location

Forest Investigative Site 035

Baltimore, Maryland, 21204, United States

Location

Forest Investigative Site 046

Oxon Hill, Maryland, 20745, United States

Location

Forest Investigative Site 118

New Bedford, Massachusetts, 02740, United States

Location

Forest Investigative Site 007

Waltham, Massachusetts, 02453, United States

Location

Forest Investigative Site 002

Dearborn, Michigan, 48126, United States

Location

Forest Investigative Site 029

Saint Clair Shores, Michigan, 48081, United States

Location

Forest Investigative Site 054

Edina, Minnesota, 55435, United States

Location

Forest Investigative Site 013

Grand Island, Nebraska, 68803, United States

Location

Forest Investigative Site 072

Las Vegas, Nevada, 89101, United States

Location

Forest Investigative Site 065

Las Vegas, Nevada, 89117, United States

Location

Forest Investigative Site 081

New Hyde Park, New York, 11042, United States

Location

Forest Investigative Site 016

New York, New York, 10019, United States

Location

Forest Investigative Site 094

Charlotte, North Carolina, 28204, United States

Location

Forest Investigative Site 051

Charlotte, North Carolina, 28209, United States

Location

Forest Investigative Site 117

Charlotte, North Carolina, 28277, United States

Location

Forest Investigative Site 058

Lenoir, North Carolina, 28645, United States

Location

Forest Investigative Site 038

Morehead City, North Carolina, 28557, United States

Location

Forest Investigative Site 040

Salisbury, North Carolina, 28144, United States

Location

Forest Investigative Site 039

Akron, Ohio, 44311, United States

Location

Forest Investigative Site 023

Cincinnati, Ohio, 45242, United States

Location

Forest Investigative Site 043

Columbus, Ohio, 43201, United States

Location

Forest Investigative Site 057

Dayton, Ohio, 45406, United States

Location

Forest Investigative Site 032

Kettering, Ohio, 45429, United States

Location

Forest Investigative Site 149

Norman, Oklahoma, 73069, United States

Location

Forest Investigative Site 102

Ashland, Oregon, 97520, United States

Location

Forest Investigative Site 005

Eugene, Oregon, 97404, United States

Location

Forest Investigative Site 037

Harleysville, Pennsylvania, 19438, United States

Location

Forest Investigative Site 066

Philadelphia, Pennsylvania, 19152, United States

Location

Forest Investigative Site 036

Tipton, Pennsylvania, 16684, United States

Location

Forest Investigative Site 103

Greer, South Carolina, 29651, United States

Location

Forest Investigative Site 090

Manning, South Carolina, 29102, United States

Location

Forest Investigative Site 033

Pelzer, South Carolina, 29669, United States

Location

Forest Investigative Site 114

Chattanooga, Tennessee, 37404, United States

Location

Forest Investigative Site 104

Chattanooga, Tennessee, 37421, United States

Location

Forest Investigative Site 099

Arlington, Texas, 76014, United States

Location

Forest Investigative Site 056

Corpus Christi, Texas, 78404, United States

Location

Forest Investigative Site 017

Dallas, Texas, 75235, United States

Location

Forest Investigative Site 124

Dallas, Texas, 75251, United States

Location

Forest Investigative Site 106

Houston, Texas, 77079, United States

Location

Forest Investigative Site 014

Irving, Texas, 75039, United States

Location

Forest Investigative Site 109

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 076

Salt Lake City, Utah, 84107, United States

Location

Forest Investigative Site 028

Virginia Beach, Virginia, 23454, United States

Location

Forest Investigative Site 092

Spokane, Washington, 99207, United States

Location

Forest Investigative Site 027

Milwaukee, Wisconsin, 53209, United States

Location

Forest Investigative Site 209

Mogilev, Belarus, 212030, Belarus

Location

Forest Investigative Site 401

Dresden, Germany, 01099, Germany

Location

Forest Investigative Site 402

Dresden, Germany, 01307, Germany

Location

Forest Investigative Site 403

Mainz, Germany, 55116, Germany

Location

Forest Investigative Site 614

Vijayawada, Andhra Pradesh, 520002, India

Location

Forest Investigative Site 618

Ahmedabad, Gujarat, 380015, India

Location

Forest Investigative Site 620

Haryāna, Karnal, 132001, India

Location

Forest Investigative Site 607

Bangalore, Karnataka, 560003, India

Location

Forest Investigative Site 606

Bangalore, Karnataka, 560010, India

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Forest Investigative Site 602

Bangalore, Karnataka, 560043, India

Location

Forest Investigative Site 604

Bangalore, Karnataka, 560092, India

Location

Forest Investigative Site 601

Mangalore, Karnataka, 575003, India

Location

Forest Investigative Site 616

Nagpur, Maharashtra, 440012, India

Location

Forest Investigative Site 617

Nashik, Maharashtra, 380015, India

Location

Forest Investigative Site 612

Pune, Maharashtra, 411037, India

Location

Forest Investigative Site 603

Channi, Tamil Nadu, 600020, India

Location

Forest Investigative Site 613

Chennai, Tamil Nadu, 600013, India

Location

Forest Investigative Site 615

Vellore, Tamil Nadu, 632009, India

Location

Forest Investigative Site 702

Kaunas, Lithunia, 48259, Lithuania

Location

Forest Investigative Site 703

Kaunas, Lithunia, 49456, Lithuania

Location

Forest Investigative Site 704

Klaipėda, Lithunia, 92288, Lithuania

Location

Forest Investigative Site 705

Vilnius, Lithunia, 09112, Lithuania

Location

Forest Investigative Site 909

Bacau, Romania, 600164, Romania

Location

Forest Investigative Site 906

Bucharest, Romania, 010584, Romania

Location

Forest Investigative Site 908

Bucharest, Romania, 020725, Romania

Location

Forest Investigative Site 903

Satu Mare, Romania, 440055, Romania

Location

Forest Investigative Site 901

Sibiu, Romania, 550245, Romania

Location

Forest Investigative Site 905 Romania

Tg Mures, Romania, 540142, Romania

Location

Forest Investigative Site 902

Timișoara, Romania, 300736, Romania

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dutogliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kaity Posada, PharmD

  Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

  STUDY DIRECTOR

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: September 1, 2009
• First Posted: September 2, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2010
• Last Updated: September 21, 2011

Record last verified: 2011-09

Locations

LI (4); RO (7); BE (1); US (89); DE (3); IN (14)