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
| NCT number | NCT00947557 |
| Other study ID # | DUT-MD-303 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 3 |
| First received | July 23, 2009 |
| Last updated | September 9, 2011 |
| Start date | July 2009 |
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.
| Status | Terminated |
| Enrollment | 677 |
| Est. completion date | |
| 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories | Phenomix |
United States, Belarus, Colombia, Hungary, India, Lithuania, Peru, Romania,
| 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 |
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