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Study terminated as a result of interim analysis not meeting predetermined criteria.
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The purpose of this study is to learn whether PPM-204 has an effect on lowering blood glucose (blood sugar) levels and is safe in treating people with type 2 diabetes.
The objectives of the study are to identify doses of PPM-204 that are therapeutically effective and well tolerated in improving glycemic control over 24 weeks of treatment in subjects with type 2 diabetes mellitus (T2DM).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPM-204 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose |
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes of HbA1c, Fasting Insulin, HOMA-IR and QUICKI indices, Body weight, waist measurements, total cholesterol, LDL-C, HDL-C, total/HDL, apolipoprotein A-1 & B, triglycerides, free fatty acids, hs C-reactive protein, adiponectin, edema. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Argentina, Scheima@wyeth.com | Principal Investigator |
| Trial Manager | For Australia, medinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Brazil, xavierl@wyeth.com | Principal Investigator |
| Trial Manager | For Austria, WPVIMED@wyeth.com | Principal Investigator |
| Trial Manager | For Canada, clintrialparticipation@wyeth.com | Principal Investigator |
| Trial Manager | For Chile, scheima@wyeth.com | Principal Investigator |
| Trial Manager | For China, medinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Croatia, WPBUMED@wyeth.com | Principal Investigator |
| Trial Manager |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia | California | 90701 | United States | |||
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| For Greece, decresg@wyeth.com |
| Principal Investigator |
| Trial Manager | For Hong Kong, medinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Italy, descresg@wyeth.com | Principal Investigator |
| Trial Manager | For Mexico, gomezzlj@wyeth.com | Principal Investigator |
| Trial Manager | For Romania, WVPIMED@wyeth.com | Principal Investigator |
| Trial Manager | For Russia, WVPIMED@wyeth.com | Principal Investigator |
| Trial Manager | For Serbia, WPVIMED@wyeth.com | Principal Investigator |
| Trial Manager | For South Africa, ZAFinfo@wyeth.com | Principal Investigator |
| Trial Manager | For UK/Great Britian, ukmedinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Ukraine, WVPIMED@wyeth.com | Principal Investigator |
| Los Angeles |
| California |
| 90057 |
| United States |
| Chipley | Florida | 32428 | United States |
| Destin | Florida | 32541 | United States |
| Marianna | Florida | 32446 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Omaha | Nebraska | 68131 | United States |
| New York | New York | 10032 | United States |
| Austin | Texas | 78705 | United States |
| Richmond | Virginia | 23249 | United States |
| Tacoma | Washington | 98405 | United States |
| Buenos Aires | C1117ABH | Argentina |
| Corrientes | 3400 | Argentina |
| La Plata | 1900 | Argentina |
| Mar Del Plata Pcia de Bs. As | 7600 | Argentina |
| Ramos Mejia, Pcia de Bs. | 1704 | Argentina |
| Daws Park | South Australia | 5041 | Australia |
| Keswick | South Australia | 5035 | Australia |
| Box Hill | Victoria | 3128 | Australia |
| Vila Clementino - Sao Paulo | 04020-060 | Brazil |
| Edmonton | Alberta | T5G 3G6 | Canada |
| Toronto | Ontario | M9W 4L6 | Canada |
| Charlottetown | Prince Edward Island | C1E 1J7 | Canada |
| Laval | Quebec | H7P 2P5 | Canada |
| Saint-Janvier | Quebec | J7J 2K8 | Canada |
| Beijing | 100730 | China |
| Beijing | 100853 | China |
| Krapinske Toplice | 49000 | Croatia |
| Rijeka | 51000 | Croatia |
| Zagreb | 10000 | Croatia |
| Athens | 115 21 | Greece |
| Thessaloniki | 56429 | Greece |
| Wan Chai | Hong Kong |
| Bangalore | Karnataka | 560043 | India |
| Kochi | Kerala | 682 026 | India |
| Pune | Maharashtra | 411001 | India |
| Chennai | Tamil Nadu | 600 013 | India |
| Vellore | Tamil Nadu | 632004 | India |
| Catanzaro | 88100 | Italy |
| Pisa | 56124 | Italy |
| Aguascalientes | 20230 | Mexico |
| Mexico City | 11650 | Mexico |
| Mexico City | 14000 | Mexico |
| Miguel Hidalgo | 11550 | Mexico |
| Monterrey N.L | 64410 | Mexico |
| Tlapan | 14080 | Mexico |
| Bucharest | 10825 | Romania |
| Bucharest | 20475 | Romania |
| Cluj-Napoca | 400006 | Romania |
| Moscow | 117036 | Russia |
| Moscow | 117292 | Russia |
| Moscow | 123154 | Russia |
| Moscow | 125315 | Russia |
| Saint Petersburg | 194044 | Russia |
| Saint Petersburg | 194354 | Russia |
| Belgrade | 11000 | Serbia and Montenegro |
| Port Elizabeth | Eastern Cape | 6014 | South Africa |
| Benoni | Gauteng | 1501 | South Africa |
| Pretoria | Gauteng | 0002 | South Africa |
| Pretoria | Gauteng | 39 | South Africa |
| Temba | North West | 400 | South Africa |
| Kharkiv | 61070 | Ukraine |
| Kyiv | 02175 | Ukraine |
| Poltava | 36024 | Ukraine |
| Uzhhorod | 80312 | Ukraine |
| Dundee | DD1 9SY | United Kingdom |
| Edinburgh | EH4 2XU | United Kingdom |
| Livingston | EH54 6PP | United Kingdom |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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