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

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 Pioglitazone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00970424
• Other study ID #: DUT-MD-304
• Status: Terminated
• Phase: Phase 3
• First received: September 1, 2009
• Last updated: September 9, 2011
• Start date: August 2009

Study information

• Verified date: September 2011
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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 treatment with pioglitazone.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 252
• Est. primary completion date: August 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 taking more than one oral hypoglycemic agent

• 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:
• Placebo
placebo, oral tablet administered once daily on background of pioglitazone
• Dutogliptin
dutogliptin, oral tablet administered once daily on background of pioglitazone

Locations

Country	Name	City	State
Belarus	Forest Investigative Site 209	Mogilev
Germany	Forest Investigative Site 401	Dresden
Germany	Forest Investigative Site 402	Dresden
Germany	Forest Investigative Site 403	Mainz
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 601	Mangalore	Karnataka
India	Forest Investigative Site 616	Nagpur	Maharashtra
India	Forest Investigative Site 617	Nasik	Maharashtra
India	Forest Investigative Site 612	Pune	Maharashtra
India	Forest Investigative Site 615	Vellore	Tamil Nadu
India	Forest Investigative Site 614	Vijayawada	Andhra Pradesh
Lithuania	Forest Investigative Site 702	Kaunas	Lithunia
Lithuania	Forest Investigative Site 703	Kaunas	Lithunia
Lithuania	Forest Investigative Site 704	Klaipeda	Lithunia
Lithuania	Forest Investigative Site 705	Vilnius	Lithunia
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 Romania	Tg Mures
Romania	Forest Investigative Site 902	Timisoara
United States	Forest Investigative Site 039	Akron	Ohio
United States	Forest Investigative Site 061	Anaheim	California
United States	Forest Investigative Site 099	Arlington	Texas
United States	Forest Investigative Site 102	Ashland	Oregon
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 020	Birmingham	Alabama
United States	Forest Investigative Site 064	Birmingham	Alabama
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 117	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 073	Clearwater	Florida
United States	Forest Investigative Site 115	Colorado Springs	Colorado
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 124	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 054	Edina	Minnesota
United States	Forest Investigative Site 049	Encinitas	California
United States	Forest Investigative Site 078	Erlanger	Kentucky
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 013	Grand Island	Nebraska
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 037	Harleysville	Pennsylvania
United States	Forest Investigative Site 106	Houston	Texas
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 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 096	Litchfield	Arizona
United States	Forest Investigative Site 024	Madisonville	Kentucky
United States	Forest Investigative Site 090	Manning	South Carolina
United States	Forest Investigative Site 60	Melrose Park	Illinois
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 027	Milwaukee	Wisconsin
United States	Forest Investigative Site 038	Morehead City	North Carolina
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 016	New York	New York
United States	Forest Investigative Site 149	Norman	Oklahoma
United States	Forest Investigative Site 111	Northridge	California
United States	Forest Investigative Site 015	Orlando	Florida
United States	Forest Investigative Site 046	Oxon Hill	Maryland
United States	Forest Investigative Site 033	Pelzer	South Carolina
United States	Forest Investigative Site 030	Peoria	Illinois
United States	Forest Investigative Site 066	Philadelphia	Pennsylvania
United States	Forest Investigative Site 098	Phoenix	Arizona
United States	Forest Investigative Site 031	Riverside	California
United States	Forest Investigative Site 091	Roseville	California
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 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 092	Spokane	Washington
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 087	Tucson	Arizona
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

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	Phenomix

Countries where clinical trial is conducted

United States,  Belarus,  Germany,  India,  Lithuania,  Romania, 

Outcome

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