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
Overview
- Phase
- Phase 1
- Intervention
- placebo
- Conditions
- Diabetes Mellitus Type 2
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 122
- Primary Endpoint
- Change in hemoglobin A1c (HbA1c)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
2placebo
Intervention: placebo
1active
Intervention: RO5095932
1active
Intervention: metformin
1placebo
Intervention: metformin
1placebo
Intervention: placebo
2active
Intervention: RO5095932
2active
Intervention: metformin
2placebo
Intervention: metformin
Outcomes
Primary Outcomes
Change in hemoglobin A1c (HbA1c)
Time Frame: from baseline to week 6
Safety and tolerability: AEs, laboratory parameters, ECG, body weight, vital signs
Time Frame: monitored throughout study, with weekly ECG and 2x weekly to 2-weekly laboratory assessments on study treatment and at intervals during follow-up
Secondary Outcomes
- Pharmacokinetics: blood concentration of RO5095932 after multiple dosing(multiple sampling weeks 1-4 or 1-6 respectively, and weekly during follow-up)
- Change in metabolic parameters: glucose, insulin, C-peptide(assessed after 4 or 6 weeks on study treatment)