A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

Roche

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: metformin; Drug: placebo; Drug: RO5095932

Study type: Interventional

Funder types: Industry

Identifiers

NCT00961909

NP22340

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

122 participants in 4 patient groups, including a placebo group

1active

Experimental group

Treatment:

Drug: RO5095932

Drug: metformin

Drug: RO5095932

1placebo

Placebo Comparator group

Treatment:

Drug: metformin

Drug: placebo

2active

Experimental group

Treatment:

Drug: RO5095932

Drug: metformin

Drug: RO5095932

2placebo

Placebo Comparator group

Treatment:

Drug: metformin

Drug: placebo