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

Phase 1

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Placebo; Drug: RO5095932

• Registration Number: NCT01017302
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Study Start: 2009-12
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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Exclusion Criteria

• Type 1 diabetes
• Pancreatitis
• Treatment with insulin for more than one week within 3 months prior to study start

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	RO5095932	-
3	RO5095932	-
4	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of various doses of RO5095932	Weeks 1-4, 6, 8

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics: glucose, insulin, C-peptide	Weeks 1-4, 6, 8
Safety and Tolerability of a single dose of RO5095932	Week 5, 6, 8
Pharmacokinetics: blood concentration	Weeks 1-4, 6, 8