A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00961909

Enrollment

122

Registered

2009-08-19

Start date

2009-06-30

Completion date

2010-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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.

Interventions

DRUGRO5095932

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

DRUGmetformin

stable dose

DRUGplacebo

sc once weekly for 4 weeks

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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
Change in hemoglobin A1c (HbA1c)	from baseline to week 6

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026