A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/3/2016 |
| Start Date: | June 2009 |
| End Date: | October 2010 |
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
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.
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.
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
We found this trial at
5
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials