Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.
| Status | Terminated |
| Enrollment | 700 |
| Est. completion date | December 2010 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1) - Age 18 to 85 years, inclusive. - Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive - Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of = 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1) - HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (> 0.8 ng/mL; > 281 pmol/L) at screening (Visit 1) Exclusion Criteria: - Type 1 diabetes mellitus |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Phenomix Investigational Site 401 | Buenos Aires | |
| Argentina | Phenomix Investigational Site 402 | Buenos Aires | |
| Argentina | Phenomix Investigational Site 404 | Buenos Aires | |
| Argentina | Phenomix Investigational Site 405 | Buenos Aires | |
| Argentina | Phenomix Investigational Site 406 | Buenos Aires | |
| Argentina | Phenomix Investigational Site 407 | Buenos Aires | |
| Argentina | Phenomix Investigational Site 408 | Buenos Aires | |
| Argentina | Phenomix Investigational Site 409 | Buenos Aires | |
| Argentina | Phenomix Investigational Site 411 | Buenos Aires | |
| Argentina | Phenomix Investigational Site 403 | Corrientes | |
| Argentina | Phenomix Investigational Site 410 | Mendoza | |
| Argentina | Phenomix Investigational Site 400 | Rosario | |
| Chile | Phenomix Investigational Site 502 | Santiago | |
| Chile | Phenomix Investigational Site 504 | Santiago | |
| Chile | Phenomix Investigational Site 505 | Santiago | |
| Chile | Phenomix Investigational Site 500 | Temuco | |
| Chile | Phenomix Investigational Site 501 | Temuco | |
| Czech Republic | Phenomix Investigational Site 209 | Chodov | |
| Czech Republic | Phenomix Investigational Site 205 | Havírov-Mesto | |
| Czech Republic | Phenomix Investigational Site 204 | Liberec | |
| Czech Republic | Phenomix Investigational Site 202 | Olomouc | |
| Czech Republic | Phenomix Investigational Site 206 | Ostrava Kuncice | |
| Czech Republic | Phenomix Investigational Site 208 | Praha | |
| Czech Republic | Phenomix Investigational Site 203 | Prostejov | |
| Czech Republic | Phenomix Investigational Site 207 | Unicov | |
| Czech Republic | Phenomix Investigational Site 201 | Valašské Klobouky | |
| India | Phenomix Investigational Site 701 | Bangalore | Karnataka |
| India | Phenomix Investigational Site 702 | Bangalore | Karnataka |
| India | Phenomix Investigational Site 708 | Chennai | |
| India | Phenomix Investigational Site 709 | Gopalapuram | Chennai |
| India | Phenomix Investigational Site 703 | Hyderabad | Andhara Pradesh |
| India | Phenomix Investigational Site 706 | Indore | Madhya Pradesh |
| India | Phenomix Investigational Site 711 | Mumbai | Maharastra |
| India | Phenomix Investigational Site 700 | Nashik | Maharashtra |
| India | Phenomix Investigational Site 710 | Navi Mumbai | Maharashtra |
| India | Phenomix Investigational Site 707 | Shastrinagar | Jaipur |
| India | Phenomix Investigational Site 705 | Trivandrum | Kerala |
| India | Phenomix Investigational Site 704 | Visakhapatanam | Andhra Pradesh |
| Peru | Phenomix Investigational Site 607 | Arequipa | |
| Peru | Phenomix Investigational Site 605 | Cercado de Lima | |
| Peru | Phenomix Investigational Site 601 | Ica | |
| Peru | Phenomix Investigational Site 600 | Lima | |
| Peru | Phenomix Investigational Site 603 | Lima | |
| Peru | Phenomix Investigational Site 604 | Lima | |
| Peru | Phenomix Investigational Site 608 | Lima | |
| Peru | Phenomix Investigational Site 610 | Lima | |
| Peru | Phenomix Investigational Site 606 | Piura | |
| Peru | Phenomix Investigational Site 602 | Trujillo | |
| Peru | Phenomix Investigational Site 609 | Wanchaq Cusco | |
| Poland | Phenomix Investigational Site 300 | Gdansk | |
| Poland | Phenomix Investigational Site 301 | Gdansk | |
| Poland | Phenomix Investigational Site 303 | Katowice | |
| Poland | Phenomix Investigational Site 312 | Katowice | |
| Poland | Phenomix Investigational Site 309 | Kraków | |
| Poland | Phenomix Investigational Site 313 | Kraków | |
| Poland | Phenomix Investigational Site 308 | Lublin | |
| Poland | Phenomix Investigational Site 310 | Poznan | |
| Poland | Phenomix Investigational Site 306 | Pulawy | |
| Poland | Phenomix Investigational Site 304 | Szczecin | |
| Poland | Phenomix Investigational Site 305 | Warszawa | |
| Poland | Phenomix Investigational Site 307 | Warszawa | |
| Poland | Phenomix Investigational Site 311 | Warszawa | |
| Poland | Phenomix Investigational Site 302 | Wroclaw | |
| United States | Phenomix Investigational Site 116 | Albuquerque | New Mexico |
| United States | Phenomix Investigational Site 105 | Anaheim | California |
| United States | Phenomix Investigational Site 138 | Biloxi | Mississippi |
| United States | Phenomix Investigational Site 131 | Brick | New Jersey |
| United States | Phenomix Investigational Site 136 | Brockton | Massachusetts |
| United States | Phenomix Investigational Site 135 | Chicago | Illinois |
| United States | Phenomix Investigational Site 123 | Chico | California |
| United States | Phenomix Investigational Site 130 | Cincinnati | Ohio |
| United States | Phenomix Investigational Site 143 | Coral Gables | Florida |
| United States | Phenomix Investigational Site 118 | Cuyahoga Falls | Ohio |
| United States | Phenomix Investigational Site 102 | Dallas | Texas |
| United States | Phenomix Investigational Site 139 | Dallas | Texas |
| United States | Phenomix Investigational Site 141 | Dunwoody | Georgia |
| United States | Phenomix Investigational Site 126 | El Paso | Texas |
| United States | Phenomix Investigational Site 134 | Escondido | California |
| United States | Phenomix Investigational Site 112 | Greenville | South Carolina |
| United States | Phenomix Investigational Site 142 | Hialeah | Florida |
| United States | Phenomix Investigational Site 101 | Honolulu | Hawaii |
| United States | Phenomix Investigational Site 124 | Indianapolis | Indiana |
| United States | Phenomix Investigational Site 127 | Indianapolis | Indiana |
| United States | Phenomix Investigational Site 119 | Jacksonville | Florida |
| United States | Phenomix Investigational Site 125 | Kalamazoo | Michigan |
| United States | Phenomix Investigational Site 100 | Kenosha | Wisconsin |
| United States | Phenomix Investigational Site 133 | Kissimmee | Florida |
| United States | Phenomix Investigational Site 122 | Las Vegas | Nevada |
| United States | Phenomix Investigational Site 140 | Las Vegas | Nevada |
| United States | Phenomix Investigational Site 103 | Long Beach | California |
| United States | Phenomix Investigational Site 106 | Los Angeles | California |
| United States | Phenomix Investigational Site 115 | Montgomery | Alabama |
| United States | Phenomix Investigational Site 104 | San Antonio | Texas |
| United States | Phenomix Investigational Site 121 | Tempe | Arizona |
| United States | Phenomix Investigational Site 137 | Tempe | Arizona |
| United States | Phenomix Investigational Site 110 | Trenton | New Jersey |
| United States | Phenomix Investigational Site 107 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Phenomix | Forest Laboratories |
United States, Argentina, Chile, Czech Republic, India, Peru, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline. | 26 weeks | No | |
| Secondary | Demonstrate safety and tolerability of dutogliptin | 26 weeks | Yes | |
| Secondary | • Demonstrate changes in fasting plasma glucose | 26 weeks | No |
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