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This randomized, double-blind, placebo-controlled study will assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO5095932 subcutaneously once weekly or placebo for 4 weeks (part 1) or 6 weeks (part 2), in addition to their current stable doses of metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1active | Experimental |
| |
| 1placebo | Placebo Comparator |
| |
| 2active | Experimental |
| |
| 2placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5095932 | Drug | cohorts receiving multiple ascending doses, sc once weekly for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs | monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up | |
| Change in hemoglobin A1c (HbA1c) | from baseline to week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: blood concentration of RO5095932 after multiple dosing | multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up | |
| Change in metabolic parameters: glucose, insulin, C-peptide | assessed after 4 or 6 weeks on study treatment |
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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 |
|---|---|---|---|---|---|---|
| Anaheim | California | 92801 | 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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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| RO5095932 |
| Drug |
dose titration to target dose, sc once weekly for 6 weeks |
|
| metformin | Drug | stable dose |
|
| placebo | Drug | sc once weekly for 4 weeks |
|
| Chula Vista |
| California |
| 91911 |
| United States |
| Fort Myers | Florida | 33901 | United States |
| Miramar | Florida | 33025 | United States |
| San Antonio | Texas | 78209 | United States |
| San Antonio | Texas | 78229-4801 | United States |
| D004700 | Endocrine System Diseases |