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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dutogliptin | Drug | dutogliptin 400 mg, once daily tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate safety and tolerability of dutogliptin | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate maintenance or lowering of HbA1c | Two years | |
| To demonstrate maintenance or lowering of fasting blood glucose | Two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwalk | California | United States | ||||
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| Orange |
| California |
| United States |
| Santa Ana | California | United States |
| Daytona Beach | Florida | United States |
| Kissimmee | Florida | United States |
| Atlanta | Georgia | United States |
| Phenomix Investigational Site 663 | Honolulu | Hawaii | United States |
| Brockton | Massachusetts | United States |
| St Louis | Missouri | United States |
| Cincinnati | Ohio | United States |
| El Paso | Texas | United States |
| San Antonio | Texas | United States |
| Norfolk | Virginia | United States |
| Phenomix Investigational Site 103 | Buenos Aires | Argentina |
| Phenomix Investigational Site 110 | Buenos Aires | Argentina |
| Phenomix Investigational Site 111 | Buenos Aires | Argentina |
| Phenomix Investigational Site 106 | Caba | Argentina |
| Phenomix Investigational Site 112 | Corrientes | Argentina |
| Phenomix Investigational Site 102 | Paraná | Argentina |
| Bangalore, Karnataka | India |
| Chennai, Tamil Nadu | India |
| Gulbarga, Karnataka | India |
| Hyderabad, Andhara Pradesh | India |
| Mumbai, Maharashtra | India |
| Nagpur, Maharashtra | India |
| Nashik, Maharashtra | India |
| Navi Mumbai, Maharashtra | India |
| Pune, Maharashtra | India |
| Phenomix Investigational Site 403 | Kuching | Sarawak | Malaysia |
| Kelantan | Malaysia |
| Kuala Lumpur | Malaysia |
| Perak | Malaysia |
| Phenomix Investigational Site 404 | Putrajaya | Malaysia |
| Sarawak | Malaysia |
| Phenomix Investigational Site 604 | Arequipa | Peru |
| Phenomix Investigational Site 606 | Lambayeque | Peru |
| Phenomix Investigational Site 600 | Lima | Peru |
| Phenomix Investigational Site 601 | Lima | Peru |
| Phenomix Investigational Site 602 | Lima | Peru |
| Phenomix Investigational Site 609 | Lima | Peru |
| Phenomix Investigational Site 703 | Cebu City | Philippines |
| Manila, NCR | Philippines |
| Quezon City, NCR | Philippines |
| San Juan, NCR | Philippines |
| Phenomix Investigational Site 802 | Brasov | Romania |
| Phenomix Investigational Site 806 | Brasov | Romania |
| Phenomix Investigational Site 800 | Bucharest | Romania |
| Phenomix Investigational Site 803 | Bucharest | Romania |
| Phenomix Investigational Site 805 | Bucharest | Romania |
| Phenomix Investigational Site 807 | Bucharest | Romania |
| Phenomix Investigational Site 804 | Galati | Romania |
| Phenomix Investigational Site 801 | Ploieşti | Romania |
| Phenomix Investigational Site 808 | Sibiu | Romania |
| Phenomix Investigational Site 551 | Ivano-Frankivsk | Ukraine |
| Phenomix Investigational Site 550 | Kharkiv | Ukraine |
| Phenomix Investigational Site 557 | Kharkiv | Ukraine |
| Phenomix Investigational Site 564 | Kharkiv | Ukraine |
| Phenomix Investigational Site 555 | Kiev | Ukraine |
| Phenomix Investigational Site 556 | Kiev | Ukraine |
| Phenomix Investigational Site 562 | Kiev | Ukraine |
| Phenomix Investigational Site 563 | Kiev | Ukraine |
| Phenomix Investigational Site 554 | Kylv | Ukraine |
| Phenomix Investigational Site 565 | Lutsk | Ukraine |
| Phenomix Investigational Site 553 | Lviv | Ukraine |
| Phenomix Investigational Site 561 | Poltava | Ukraine |
| Phenomix Investigational Site 560 | Simferopol | Ukraine |
| Phenomix Investigational Site 559 | Vinnitsa | Ukraine |
| Phenomix Investigational Site 552 | Zaporzhzhia | Ukraine |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C552164 | dutogliptin |
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