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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003575-47 |
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This 3 arm, placebo-controlled study will investigate the effect of Taspoglutide on gastric emptying in patients with type 2 diabetes. Patients will be randomized into one of 3 groups to receive a)10mg Taspoglutide sc weekly for 12 weeks b)10mg Taspoglutide sc weekly for 4 weeks followed by 20mg Taspoglutide sc weekly for 8 weeks or c) placebo sc weekly for 12 weeks, with all injections administered in the abdomen.Gastric emptying will be assessed by a paracetamol test at intervals during the study. The anticipated time on study treatment is 3 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | sc once weekly for 12 weeks |
| |
| taspoglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax, log (AUC), log(Cmax)of paracetamol | Days -1, 1, 5, 29, 33, 78 and 82 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, laboratory parameters, vital signs | Throughout study | |
| renal function (creatinine clearance, urine volume and electrolytes) | Throughout study | |
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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 |
|---|---|---|---|---|---|---|
| Berlin | 14050 | Germany | ||||
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C541736 | taspoglutide |
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| Drug |
10mg sc once weekly for 4 weeks, followed by 20mg sc once weekly for 8 weeks |
|
| taspoglutide | Drug | 10mg sc once weekly for 12 weeks |
|
| Multiple dose pharmacokinetics of Taspoglutide |
| Throughout study |
| Neuss |
| 41460 |
| Germany |
| London | HA1 3UJ | United Kingdom |
| D004700 | Endocrine System Diseases |