A Multiple Ascending Dose Study of RO4998452 in Patients With Type 2 Diabetes Mellitus.
Completed · Phase 1 · Has a placebo group
Conditions studied: Diabetes Mellitus Type 2
In brief
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.
Key facts
- Study ID
- NCT00682097
- Run by
- Hoffmann-La Roche
- People needed
- 55
- Starts
- 2008-05-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- adult patients, 18-65 years of age;
- type 2 diabetes;
- either treated by diet and exercise alone or with metformin.
You may not qualify if…
- type 1 diabetes mellitus;
- uncontrolled hypertension;
- clinically severe diabetic complications.
Where it is running
- Study site — Chula Vista, California, United States
- Study site — San Antonio, Texas, United States
- Study site — Neuss, Germany
Full record on ClinicalTrials.gov
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