A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

Phase 1CompletedNCT00961909

Hoffmann-La Roche122 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

122

Conditions

Diabetes Mellitus Type 2

Interventions

RO5095932DRUG

cohorts receiving multiple ascending doses, sc once weekly for 4 weeks

RO5095932DRUG

dose titration to target dose, sc once weekly for 6 weeks

metforminDRUG

stable dose

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 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

Locations (6)

Unnamed facility

Anaheim, California, United States

Unnamed facility

Chula Vista, California, United States

Unnamed facility

Fort Myers, Florida, United States

Unnamed facility

Miramar, Florida, United States

Outcomes

Primary Outcomes

Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs

Time frame: 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)

Time frame: from baseline to week 6

Secondary Outcomes

Pharmacokinetics: blood concentration of RO5095932 after multiple dosing

Time frame: multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up

Change in metabolic parameters: glucose, insulin, C-peptide

Time frame: assessed after 4 or 6 weeks on study treatment

Data from ClinicalTrials.gov

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