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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003582-97 |
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This crossover study will assess the effect of 2 doses of Taspoglutide on first- and second-phase insulin secretion in patients with type 2 diabetes. Patients will receive a continuous subcutaneous infusion of a)the Immediate Release Formulation (IRF)of Taspoglutide 300 micrograms/day for 2 days followed by Taspoglutide 800 micrograms/day for 2 days or b)saline placebo for 2+2 days. After a washout period of 10-15 days, patients will be crossed-over for further treatment;those receiving Taspoglutide in period 1 will receive placebo in period 2, and vice versa. On days 2 and 4 of each period, insulin secretion patterns will be assessed. 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | sc for 4 days |
| |
| taspoglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental area under insulin concentration time curve relative to basal insulin concentration | First 10 minutes after glucose bolus |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental area under insulin concentration time curve relative to basal insulin concentration | 10-120 minutes after glucose bolus | |
| Adverse events, laboratory parameters | 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 |
|---|---|---|---|---|---|---|
| Neuss | 41460 | 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 |
300micrograms/day sc for 2 days |
|
| taspoglutide | Drug | 800 micrograms/day sc for 2 days |
|
| D004700 | Endocrine System Diseases |