Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Glimepiride With or Without Metformin

NCT00947557 | Terminated Phase 3

• 1 other identifier: DUT-MD-303
• Study Type: interventional
• Target: 677
• Locations: 8 countries
• Sites: 147

Brief Summary

This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy of glimepiride with or without metformin.

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c (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), Visit 8 (Week 26).

Secondary Outcomes (1)

• Fasting Plasma Glucose (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), Visit 8 (Week 26).

Study Arms (2)

Dutogliptin

ACTIVE COMPARATOR

Dutogliptin

Drug: Dutogliptin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Dutogliptin DRUG

Dutogliptin oral administration once daily on background of glimepiride with or without metformin

Dutogliptin

Placebo DRUG

Placebo, oral administration once daily on background of glimepiride with or without metformin

Placebo

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 on 3 or more oral antidiabetic drugs or insulin.
• Type 1 diabetes mellitus

Sponsors & Collaborators

• Forest Laboratories: lead
• Phenomix: collaborator

Study Sites (147)

Forest Investigative Site 064

Birmingham, Alabama, 35205, United States

Location

Forest Investigative Site 020

Birmingham, Alabama, 35235, United States

Location

Forest Investigative Site 025

Muscle Shoals, Alabama, 35661, United States

Location

Forest Investigative Site 059

Chandler, Arizona, 85225, United States

Location

Forest Investigative Site 113

Gilbert, Arizona, 85295, United States

Location

Forest Investigative Site 096

Litchfield, Arizona, 85340, United States

Location

Forest Investigative Site 080

Peoria, Arizona, 85381, 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 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 070

Los Angeles, California, 90057, 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 088

Denver, Colorado, 80239, United States

Location

Forest Investigative Site 156

Boca Raton, Florida, 33432, 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 129

Hollywood, Florida, 33021, United States

Location

Forest Investigative Site 062

Jacksonville, Florida, 32205, United States

Location

Forest Investigative Site 050

Miami, Florida, 33156, United States

Location

Forest Investigative Site 021

Miami, Florida, 33169, United States

Location

Forest Investigative Site 122

Miami, Florida, 33186, United States

Location

Forest Investigative Site 125

Miami Lakes, Florida, 33014, United States

Location

Forest Investigative Site 069

New Port Richey, Florida, 34652, United States

Location

Forest Investigative Site 012

Ocala, Florida, 34471, United States

Location

Forest Investigative Site 015

Orlando, Florida, 32806, United States

Location

Forest Investigative Site 131

Ormond Beach, Florida, 32174, United States

Location

Forest Investigative Site 127

Pembroke Pines, Florida, 33028, 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 084

Roswell, Georgia, 30076, United States

Location

Forest Investigative Site 132

Roswell, Georgia, 30076, United States

Location

Forest Investigative Site 009

Meridian, Idaho, 83646, 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 107

Lexington, Kentucky, 40504, 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 003

Brockton, Massachusetts, 02301, United States

Location

Forest Investigative Site 055

Brockton, Massachusetts, 23301, United States

Location

Forest Investigative Site 118

New Bedford, Massachusetts, 02740, United States

Location

Forest Investigative Site 007

Waltham, Massachusetts, 24453, 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 072

Las Vegas, Nevada, 89101, United States

Location

Forest Investigative Site 065

Las Vegas, Nevada, 89117, United States

Location

Forest Investigative Site 101

Albuquerque, New Mexico, 87108, 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 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 082

Winston-Salem, North Carolina, 27103, 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 083

Bethany, Oklahoma, 73008, United States

Location

Forest Investigative Site 005

Eugene, Oregon, 97404, United States

Location

Forest Investigative Site 001

Medford, Oregon, 97504, United States

Location

Forest Investigative Site 126

Jenkintown, Pennsylvania, 19046, 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 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 071

Dallas, Texas, 75230, United States

Location

Forest Investigative Site 017

Dallas, Texas, 75235, 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 119

San Antonio, Texas, 78258, 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 068

Renton, Washington, 98057, United States

Location

Forest Investigative Site 208

Grodno, Belarus, 230015, Belarus

Location

Forest Investigative Site 202

Homyel, Belarus, 236029, Belarus

Location

Forest Investigative Site 207

Minsk, Belarus, 220114, Belarus

Location

Forest Investigative Site 209

Mogilev, Belarus, 212030, Belarus

Location

Forest Investigative Site 206

Vitebsk, Belarus, 210037, Belarus

Location

Forest Investigative Site 302

Medellín, Antioquia, Colombia

Location

Forest Investigative Site 506

Budapest, Hungary, H-1083, Hungary

Location

Forest Investigative Site 504

Szentes, Hungary, H-6600, Hungary

Location

Forest Investigative Site 621

Hyderabad, Andhra Pradesh, 500034, India

Location

Forest Investigative Site 614

Vijayawada, Andhra Pradesh, 520002, India

Location

Forest Investigative Site 610

Visakhapatanam, Andhra Pradesh, 530002, India

Location

Forest Investigative Site 609

Mapusa, Goa, 403507, 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

Location

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 619

Palakkad, Kerala, 678013, 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, Lithuania, 48259, Lithuania

Location

Forest Investigative Site 703

Kaunas, Lithuania, 49456, Lithuania

Location

Forest Investigative Site 701

Kaunas, Lithuania, 51270, Lithuania

Location

Forest Investigative Site 704

Klaipėda, Lithuania, 92288, Lithuania

Location

Forest Investigative Site 705

Vilnius, Lithuania, 09112, Lithuania

Location

Forest Investigative Site 804

Arequipa, Arequipa, 804, Peru

Location

Forest Investigative Site 803

Arequipa, Arequipa, Peru

Location

Forest Investigative Site 812

Trujillo, La Libertad, Peru

Location

Forest Investigative Site 811

Chiclayo, Lambayeque, Peru

Location

Forest Investigative Site 805

Lima, Lima Province, Lima 14, Peru

Location

Forest Investigative Site 813

Lima, Lima Province, Lima 17, Peru

Location

Forest Investigative Site 801

Lima, Lima Province, Lima 27, Peru

Location

Forest Investigative Site 807

Lima, Lima Province, Lima 27, Peru

Location

Forest Investigative Site 809

Lima, Lima Province, Lima 33, Peru

Location

Forest Investigative Site 808

Lima, Lima Province, Lima 41, Peru

Location

Forest Investigative Site 802

Piura, Piura, Peru

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

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: July 23, 2009
• First Posted: July 28, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Last Updated: September 21, 2011

Record last verified: 2011-09

Locations

PE (11); US (98); IN (18); RO (7); LI (5); CO (1); BE (5); HU (2)