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
Overview
- Phase
- Phase 1
- Intervention
- RO4998452
- Conditions
- Diabetes Mellitus Type 2
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 55
- Primary Endpoint
- AUC0-24h, Cmax
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
1
Intervention: RO4998452
1
Intervention: placebo
2
Intervention: RO4998452
2
Intervention: placebo
3
Intervention: RO4998452
3
Intervention: placebo
4
Intervention: RO4998452
4
Intervention: placebo
5
Intervention: RO4998452
5
Intervention: placebo
6
Intervention: RO4998452
6
Intervention: placebo
7
Intervention: RO4998452
7
Intervention: placebo
Outcomes
Primary Outcomes
AUC0-24h, Cmax
Time Frame: Days 1 and 14
AEs, laboratory parameters, vital signs.
Time Frame: Throughout study
Secondary Outcomes
- Parameters of glucose metabolism(Throughout study)