Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This 4 arm study will evaluate the tolerability, efficacy and pharmacodynamics of different doses 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 (at a dose of 20mg, or a starting dose of 20mg escalating to either 30mg or 40mg), weekly. 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | sc weekly |
|
| Taspoglutide 20mg | Experimental | sc weekly |
|
| Taspoglutide 20mg-30mg | Experimental | sc weekly |
|
| Taspoglutide 20mg-40mg | Experimental | sc weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | sc weekly |
| |
| Taspoglutide 20mg |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients withdrawn because of gastrointestinal effects | Week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean changes in 24h blood glucose Area Under the Curve (AUC), Fasting Plasma Glucose (FPG), fructosamine, Hemoglobin A1c (HbA1c), body weight, Adverse Events (AEs), laboratory parameters. | Week 9 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harrisburg | Arkansas | 72432 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20536952 | Derived | Ratner R, Nauck M, Kapitza C, Asnaghi V, Boldrin M, Balena R. Safety and tolerability of high doses of taspoglutide, a once-weekly human GLP-1 analogue, in diabetic patients treated with metformin: a randomized double-blind placebo-controlled study. Diabet Med. 2010 May;27(5):556-62. doi: 10.1111/j.1464-5491.2010.02990.x. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
sc weekly |
|
| Taspoglutide 20mg-30mg | Drug | sc weekly |
|
| Taspoglutide 20mg-40mg | Drug | sc weekly |
|
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Jonesboro | Arkansas | 72401 | United States |
| National City | California | 91950 | United States |
| Jacksonville | Florida | 32216 | United States |
| Madisonville | Kentucky | 42431 | United States |
| Hyattsville | Maryland | 20783 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Dallas | Texas | 75230 | United States |
| Dallas | Texas | 75231 | United States |
| Richmond | Virginia | 23294 | United States |
| Adelaide | 5000 | Australia |
| Camperdown | 2050 | Australia |
| Besançon | 25030 | France |
| Corbeil-Essonnes | 91106 | France |
| Narbonne | 11108 | France |
| Paris | 75877 | France |
| Poitiers | 86021 | France |
| Berlin | 10115 | Germany |
| München | 80636 | Germany |
| Neuss | 41460 | Germany |
| Chihuahua City | 31238 | Mexico |
| Culiacán | 80020 | Mexico |
| Monterrey | 64410 | Mexico |
| Tampico | 89109 | Mexico |
| Lima | 10 | Peru |
| Lima | 31 | Peru |
| Lima | LIMA 29 | Peru |
| Ponce | 00716 | Puerto Rico |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C541736 | taspoglutide |
Not provided
Not provided
Not provided