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This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is <6 months. The target sample size is <100 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Subcutenaous once weekly for 4 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of various doses of RO5095932 | Weeks 1-4, 6, 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of a single dose of RO5095932 | Week 5, 6, 8 | |
| Pharmacokinetics: blood concentration | Weeks 1-4, 6, 8 | |
| Pharmacodynamics: glucose, insulin, C-peptide |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio | Texas | 78229 | United States |
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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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| Drug |
Single subcutaneous dose in week 5 |
|
| RO5095932 | Drug | Escalating subcutaneous doses once weekly over a 4 weeks period |
|
| RO5095932 | Drug | Single subcutenaous dose in week 5 |
|
| Weeks 1-4, 6, 8 |
| D004700 | Endocrine System Diseases |