A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.

A Randomized, Double-blind, Placebo-controlled, Titration Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose and Escalating Doses of RO5095932 in Patients With Type 2 Diabetes Mellitus on Stable Background Therapy

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01017302

Enrollment

Registered

2009-11-20

Start date

2009-12-31

Completion date

2011-08-31

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 evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is \<6 months. The target sample size is \<100 patients.

Interventions

DRUGPlacebo

Subcutenaous once weekly for 4 weeks

DRUGRO5095932

Escalating subcutaneous doses once weekly over a 4 weeks period

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

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 * Diabetes mellitus, type 2 for at least 6 months before screening * On treatment with stable doses of metformin for at least 3 months before screening * BMI between \>/=25 and \</=39

Exclusion criteria

* Type 1 diabetes * Pancreatitis * Treatment with insulin for more than one week within 3 months prior to study start

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability of various doses of RO5095932	Weeks 1-4, 6, 8

Secondary

Measure	Time frame
Safety and Tolerability of a single dose of RO5095932	Week 5, 6, 8
Pharmacokinetics: blood concentration	Weeks 1-4, 6, 8
Pharmacodynamics: glucose, insulin, C-peptide	Weeks 1-4, 6, 8

Countries

United States

Outcome results

None listed

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