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

Diabetes Mellitus, Type II Clinical Trial

Official title:

A Phase III, Randomized, Double-Blind, Placebo-controlled, Multicenter Study To Evaluate The Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Glimepiride With or Without Metformin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00947557
• Other study ID #: DUT-MD-303
• Status: Terminated
• Phase: Phase 3
• First received: July 23, 2009
• Last updated: September 9, 2011
• Start date: July 2009

Study information

• Verified date: September 2011
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelarus: Ministry of HealthColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosHungary: National Institute of PharmacyIndia: Ministry of HealthLithuania: State Medicine Control Agency - Ministry of HealthPeru: Ministry of HealthRomania: National Medicines AgencyGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 677
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Currently on 3 or more oral antidiabetic drugs or insulin.

• Type 1 diabetes mellitus

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Drug:
• Dutogliptin
Dutogliptin oral administration once daily on background of glimepiride with or without metformin
• Placebo
Placebo, oral administration once daily on background of glimepiride with or without metformin

Locations

Country	Name	City	State
Belarus	Forest Investigative Site 202	Gomel
Belarus	Forest Investigative Site 208	Grodno
Belarus	Forest Investigative Site 207	Minsk
Belarus	Forest Investigative Site 209	Mogilev
Belarus	Forest Investigative Site 206	Vitebsk
Colombia	Forest Investigative Site 302	Medellin	Antioquia
Hungary	Forest Investigative Site 506	Budapest
Hungary	Forest Investigative Site 504	Szentes
India	Forest Investigative Site 618	Ahmedabad	Gujarat
India	Forest Investigative Site 602	Bangalore	Karnataka
India	Forest Investigative Site 604	Bangalore	Karnataka
India	Forest Investigative Site 606	Bangalore	Karnataka
India	Forest Investigative Site 607	Bangalore	Karnataka
India	Forest Investigative Site 603	Channi	Tamil Nadu
India	Forest Investigative Site 613	Chennai	Tamil Nadu
India	Forest Investigative Site 620	Haryana	Karnal
India	Forest Investigative Site 621	Hyderabad	Andhra Pradesh
India	Forest Investigative Site 601	Mangalore	Karnataka
India	Forest Investigative Site 609	Mapusa	Goa
India	Forest Investigative Site 616	Nagpur	Maharashtra
India	Forest Investigative Site 617	Nasik	Maharashtra
India	Forest Investigative Site 619	Palakkad	Kerala
India	Forest Investigative Site 612	Pune	Maharashtra
India	Forest Investigative Site 615	Vellore	Tamil Nadu
India	Forest Investigative Site 614	Vijayawada	Andhra Pradesh
India	Forest Investigative Site 610	Visakhapatanam	Andhra Pradesh
Lithuania	Forest Investigative Site 701	Kaunas
Lithuania	Forest Investigative Site 702	Kaunas
Lithuania	Forest Investigative Site 703	Kaunas
Lithuania	Forest Investigative Site 704	Klaipeda
Lithuania	Forest Investigative Site 705	Vilnius
Peru	Forest Investigative Site 803	Arequipa
Peru	Forest Investigative Site 804	Arequipa
Peru	Forest Investigative Site 811	Chiclayo	Lambayeque
Peru	Forest Investigative Site 801	Lima
Peru	Forest Investigative Site 805	Lima
Peru	Forest Investigative Site 807	Lima
Peru	Forest Investigative Site 808	Lima
Peru	Forest Investigative Site 809	Lima
Peru	Forest Investigative Site 813	Lima
Peru	Forest Investigative Site 802	Piura
Peru	Forest Investigative Site 812	Trujillo	La Libertad
Romania	Forest Investigative Site 909	Bacau
Romania	Forest Investigative Site 906	Bucuresti
Romania	Forest Investigative Site 908	Bucuresti
Romania	Forest Investigative Site 903	Satu Mare
Romania	Forest Investigative Site 901	Sibiu
Romania	Forest Investigative Site 905	Tg Mures
Romania	Forest Investigative Site 902	Timisoara
United States	Forest Investigative Site 039	Akron	Ohio
United States	Forest Investigative Site 101	Albuquerque	New Mexico
United States	Forest Investigative Site 061	Anaheim	California
United States	Forest Investigative Site 099	Arlington	Texas
United States	Forest Investigative Site 045	Atlanta	Georgia
United States	Forest Investigative Site 079	Augusta	Georgia
United States	Forest Investigative Site 035	Baltimore	Maryland
United States	Forest Investigative Site 083	Bethany	Oklahoma
United States	Forest Investigative Site 020	Birmingham	Alabama
United States	Forest Investigative Site 064	Birmingham	Alabama
United States	Forest Investigative Site 156	Boca Raton	Florida
United States	Forest Investigative Site 003	Brockton	Massachusetts
United States	Forest Investigative Site 055	Brockton	Massachusetts
United States	Forest Investigative Site 059	Chandler	Arizona
United States	Forest Investigative Site 051	Charlotte	North Carolina
United States	Forest Investigative Site 094	Charlotte	North Carolina
United States	Forest Investigative Site 104	Chattanooga	Tennessee
United States	Forest Investigative Site 114	Chattanooga	Tennessee
United States	Forest Investigative Site 041	Chula Vista	California
United States	Forest Investigative Site 023	Cincinnati	Ohio
United States	Forest Investigative Site 043	Columbus	Ohio
United States	Forest Investigative Site 056	Corpus Christi	Texas
United States	Forest Investigative Site 034	Covington	Louisiana
United States	Forest Investigative Site 017	Dallas	Texas
United States	Forest Investigative Site 071	Dallas	Texas
United States	Forest Investigative Site 057	Dayton	Ohio
United States	Forest Investigative Site 004	Daytona Beach	Florida
United States	Forest Investigative Site 002	Dearborn	Michigan
United States	Forest Investigative Site 052	DeLand	Florida
United States	Forest Investigative Site 088	Denver	Colorado
United States	Forest Investigative Site 054	Edina	Minnesota
United States	Forest Investigative Site 049	Encinitas	California
United States	Forest Investigative Site 005	Eugene	Oregon
United States	Forest Investigative Site 097	Evansville	Indiana
United States	Forest Investigative Site 100	Evansville	Indiana
United States	Forest Investigative Site 113	Gilbert	Arizona
United States	Forest Investigative Site 022	Greenbrae	California
United States	Forest Investigative Site 103	Greer	South Carolina
United States	Forest Investigative Site 047	Harbor City	California
United States	Forest Investigative Site 129	Hollywood	Florida
United States	Forest Investigative Site 010	Huntington Park	California
United States	Forest Investigative Site 014	Irving	Texas
United States	Forest Investigative Site 062	Jacksonville	Florida
United States	Forest Investigative Site 126	Jenkintown	Pennsylvania
United States	Forest Investigative Site 053	Kansas City	Kansas
United States	Forest Investigative Site 032	Kettering	Ohio
United States	Forest Investigative Site 065	Las Vegas	Nevada
United States	Forest Investigative Site 072	Las Vegas	Nevada
United States	Forest Investigative Site 058	Lenoir	North Carolina
United States	Forest Investigative Site 107	Lexington	Kentucky
United States	Forest Investigative Site 096	Litchfield	Arizona
United States	Forest Investigative Site 070	Los Angeles	California
United States	Forest Investigative Site 001	Medford	Oregon
United States	Forest Investigative Site 009	Meridian	Idaho
United States	Forest Investigative Site 021	Miami	Florida
United States	Forest Investigative Site 050	Miami	Florida
United States	Forest Investigative Site 122	Miami	Florida
United States	Forest Investigative Site 125	Miami Lakes	Florida
United States	Forest Investigative Site 038	Morehead City	North Carolina
United States	Forest Investigative Site 025	Muscle Shoals	Alabama
United States	Forest Investigative Site 118	New Bedford	Massachusetts
United States	Forest Investigative Site 081	New Hyde Park	New York
United States	Forest Investigative Site 069	New Port Richey	Florida
United States	Forest Investigative Site 016	New York	New York
United States	Forest Investigative Site 111	Northridge	California
United States	Forest Investigative Site 012	Ocala	Florida
United States	Forest Investigative Site 015	Orlando	Florida
United States	Forest Investigative Site 131	Ormond Beach	Florida
United States	Forest Investigative Site 046	Oxon Hill	Maryland
United States	Forest Investigative Site 033	Pelzer	South Carolina
United States	Forest Investigative Site 127	Pembroke Pines	Florida
United States	Forest Investigative Site 030	Peoria	Illinois
United States	Forest Investigative Site 080	Peoria	Arizona
United States	Forest Investigative Site 066	Philadelphia	Pennsylvania
United States	Forest Investigative Site 098	Phoenix	Arizona
United States	Forest Investigative Site 068	Renton	Washington
United States	Forest Investigative Site 031	Riverside	California
United States	Forest Investigative Site 091	Roseville	California
United States	Forest Investigative Site 084	Roswell	Georgia
United States	Forest Investigative Site 132	Roswell	Georgia
United States	Forest Investigative Site 067	Sacramento	California
United States	Forest Investigative Site 040	Salisbury	North Carolina
United States	Forest Investigative Site 076	Salt Lake City	Utah
United States	Forest Investigative Site 109	San Antonio	Texas
United States	Forest Investigative Site 119	San Antonio	Texas
United States	Forest Investigative Site 112	Santa Ana	California
United States	Forest Investigative Site 018	Sarasota	Florida
United States	Forest Investigative Site 044	Scottsdale	Arizona
United States	Forest Investigative Site 029	St. Clair Shores	Michigan
United States	Forest Investigative Site 075	St. Petersburg	Florida
United States	Forest Investigative Site 036	Tipton	Pennsylvania
United States	Forest Investigative Site 028	Virginia Beach	Virginia
United States	Forest Investigative Site 011	Walnut Creek	California
United States	Forest Investigative Site 007	Waltham	Massachusetts
United States	Forest Investigative Site 063	West Hills	California
United States	Forest Investigative Site 026	West Palm Beach	Florida
United States	Forest Investigative Site 008	Wichita	Kansas
United States	Forest Investigative Site 082	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Phenomix

Countries where clinical trial is conducted

United States,  Belarus,  Colombia,  Hungary,  India,  Lithuania,  Peru,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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).	No