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This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Experimental |
| |
| 6 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | sc weekly |
| |
| taspoglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in HbAlc | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in FPG, fructosamine, body weight, fasting insulin, C-peptide, glucagon. | Week 8 | |
| Changes in lipid profile | Week 8 | |
| AEs, laboratory parameters, primary pharmacokinetic parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington D.C. | District of Columbia | 20010 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19366970 | Derived | Nauck MA, Ratner RE, Kapitza C, Berria R, Boldrin M, Balena R. Treatment with the human once-weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebo-controlled study. Diabetes Care. 2009 Jul;32(7):1237-43. doi: 10.2337/dc08-1961. Epub 2009 Apr 14. |
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| Drug |
20mg sc weekly |
|
| taspoglutide | Drug | 10mg sc every 2 weeks |
|
| taspoglutide | Drug | 5mg sc weekly |
|
| taspoglutide | Drug | 10mg sc weekly |
|
| taspoglutide | Drug | 20mg sc every 2 weeks |
|
| Throughout study |
| Woodstock |
| Georgia |
| 30189 |
| United States |
| Chicago | Illinois | 60607 | United States |
| Springfield | Illinois | 62704-1433 | United States |
| Rochester | New York | 14609 | United States |
| Portland | Oregon | 97239 | United States |
| Dallas | Texas | 75246 | United States |
| Midland | Texas | 79707 | United States |
| San Antonio | Texas | 78229 | United States |
| Richmond | Virginia | 23249 | United States |
| Adelaide | 5000 | Australia |
| Camperdown | 2050 | Australia |
| Dimitrovgrad | 6400 | Bulgaria |
| Pleven | 5800 | Bulgaria |
| Rousse | 7002 | Bulgaria |
| Sofia | 1233 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| Varna | 9010 | Bulgaria |
| Bad Lauterberg im Harz | 37431 | Germany |
| Berlin | 10115 | Germany |
| Görlitz | 02826 | Germany |
| Hanover | 30167 | Germany |
| Mainz | 55116 | Germany |
| Neuss | 41460 | Germany |
| Nuremberg | 90402 | Germany |
| Guatemala City | 01015 | Guatemala |
| Hong Kong | Hong Kong |
| Riga | 1002 | Latvia |
| Kaunas | 51270 | Lithuania |
| Klaipėda | 92304 | Lithuania |
| Vilnius | 08661 | Lithuania |
| Guadalajara | 44340 | Mexico |
| Guadalajara | 44650 | Mexico |
| Mexico City | 03100 | Mexico |
| Mexico City | 11650 | Mexico |
| Mexico City | 14080 | Mexico |
| Mexico City | 14610 | Mexico |
| Monterrey | 64460 | Mexico |
| Pachuca | 42086 | Mexico |
| Brasov | 500365 | Romania |
| Bucharest | 020475 | Romania |
| Bucharest | 050452 | Romania |
| Bucharest | Romania |
| Cluj-Napoca | 400006 | Romania |
| Jud Covasna | 520064 | Romania |
| Mures | 540011 | Romania |
| Ploieşti | 100163 | Romania |
| Satu Mare | 3900 | Romania |
| Sibiu | 550245 | Romania |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C541736 | taspoglutide |
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