A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Titration Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose and Escalating Doses of RO5095932 in Patients With Type 2 Diabetes Mellitus on Stable Background Therapy

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: Placebo
* Drug: Placebo
* Drug: RO5095932
* Drug: RO5095932


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, 18-65 years of age Diabetes mellitus, type 2 for at least 6 months before screening On treatment with stable doses of metformin for at least 3 months before screening BMI between >/=25 and </=39 Exclusion Criteria: Type 1 diabetes Pancreatitis Treatment with insulin for more than one week within 3 months prior to study start

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RO5095932<br>* Escalating subcutaneous doses once weekly over a 4 weeks period<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Subcutenaous once weekly for 4 weeks<br>|
| Experimental: 3<br> | Drug: RO5095932<br>* Single subcutenaous dose in week 5<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* Single subcutaneous dose in week 5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of various doses of RO5095932 |  | Weeks 1-4, 6, 8 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Weeks 1-4, 6, 8 |