Roche trials database

Trial information

A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

Status:

Completed

Protocol number:

NP22340

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific Title:

A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group, 2-Part Study to Investigate the Safety, Tolerability, PK, and PD of once weekly RO5095932 in Patients with Type 2 Diabetes Mellitus on a stable dose of metformin

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. Target sample size is 122.

Study phase:

I

Study type:

Interventional; Treatment; Randomized; Parallel; Safety/efficacy study

Conditions:

• Diabetes Mellitus, Type 2

Intervention type:

Drug

Intervention name:

RO5095932

Primary outcome:

1. 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
2. Change in hemoglobin A1c (HbA1c) Time frame: from baseline to week 6

Key secondary outcomes:

1. Pharmacokinetics: blood concentration of RO5095932 after multiple dosing Time frame: multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up
2. Change in metabolic parameters: glucose, insulin, C-peptide Time frame: assessed after 4 or 6 weeks on study treatment

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

Gender:

Males or Females

Age limits:

Min: 18 years Max: 65 years

Accepts healthy volunteers:

No

Anticipated start date:

June, 2009

Trial registration date:

10.03.2009

Date last updated:

06.05.2013

This trial was conducted at the following locations:

U.S.A.

• ANAHEIM, CA
• CHULA VISTA, CA
• FT. MYERS, FL
• MIRAMAR, FL
• SAN ANTONIO, TX

Link to trial result