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

Roche

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Placebo; Drug: RO5095932

Study type: Interventional

Funder types: Industry

Identifiers

NCT01017302

NP22709

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: RO5095932

Drug: RO5095932

2

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

3

Experimental group

Treatment:

Drug: RO5095932

Drug: RO5095932

4

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo