A Multiple Ascending Dose Study of RO4998452 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: | May 2008 |
| End Date: | March 2009 |
A Randomized, Double-Blind, Multiple-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO4998452 Following Oral Administrations in Patients With Type 2 Diabetes Mellitus
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes
mellitus. Successive cohorts of patients will be randomized to receive either active drug,
at escalating doses, or placebo. The anticipated time on study treatment is <3 months, and
the target sample size is <100 individuals.
multiple ascending doses of RO4998452 compared to placebo in patients with type 2 diabetes
mellitus. Successive cohorts of patients will be randomized to receive either active drug,
at escalating doses, or placebo. The anticipated time on study treatment is <3 months, and
the target sample size is <100 individuals.
Inclusion Criteria:
- adult patients, 18-65 years of age;
- type 2 diabetes;
- either treated by diet and exercise alone or with metformin.
Exclusion Criteria:
- type 1 diabetes mellitus;
- uncontrolled hypertension;
- clinically severe diabetic complications.
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