A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/3/2016 |
| Start Date: | December 2009 |
| End Date: | August 2011 |
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
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.
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.
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
Exclusion Criteria:
- Type 1 diabetes
- Pancreatitis
- Treatment with insulin for more than one week within 3 months prior to study start
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