A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: RO5095932; Drug: metformin; Drug: placebo

• Registration Number: NCT00961909
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• adult patients, 18-65 years of age
• females who are either surgically sterile or post-menopausal
• type 2 diabetes treated with a stable dose of metformin
• BMI between 25-39kg/m2
• HbA1c between 7 and 10%
• fasting plasma glucose between 7 and 13.3mmol/L

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Exclusion Criteria

• history of clinically significant cardiovascular disease
• history of clinically significant hepatic or renal disease or impairment
• recent therapy with insulin, thiazolidinedione, glucagon-like peptide-1 analogues, amylin analogues and/or DPP-IV inhibitors

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2active	RO5095932	-
1active	RO5095932	-
1placebo	placebo	-
2placebo	placebo	-
2placebo	metformin	-
1active	metformin	-
1placebo	metformin	-
2active	metformin	-

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin A1c (HbA1c)	from baseline to week 6
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

Secondary Outcome Measures

Name	Time	Method
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