A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.
- Registration Number
- NCT00517465
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
Inclusion Criteria
- adult patients, 18-65 years of age;
- type 2 diabetic patients;
- naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for >=2 weeks before first treatment.
Exclusion Criteria
- type 1 diabetes mellitus;
- clinically significant cardiovascular disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 Placebo - 1 RG1511 - 3 RG1511 - 2 RG1511 -
- Primary Outcome Measures
Name Time Method AEs, laboratory parameters, vital signs. Throughout study Glucose AUC Days -1, 1 and 8.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters Days 1 and 8 Insulin, C-peptide, glucagon and GLP-1 AUC Days -1, 1 and 8 24h glucose Days -1, 1 and 8 Lipid profiles Days -1 and 8