A Study of RO6807952 in Patients With Diabetes Mellitus Type 2
Phase 1
Completed
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Drug: PlaceboDrug: RO6807952
- Registration Number
- NCT01358929
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is 8 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- Adult patients, 18 to 70 years of age, inclusive
- Diagnosis of type 2 diabetes >/=3 months and </=10 years prior to screening
- Fasting plasma glucose >/=110 mg/dL and </=240 mg/dL
- Patients on a stable dose of metformin for at least 2 months prior to screening
- Hemoglobin HbA1c >/=6.5% and </=10.5%
- Body mass index >/=25 kg/m2 and </=42 kg/m2
- Systolic blood pressure <155 mmHg and diastolic blood pressure <95 mmHg
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Exclusion Criteria
- Patients with type 1 diabetes
- History of significant renal and hepatic diseases
- History of metabolic acidosis and diabetic gastroparesis
- History of pancreatitis
- History of coagulation disorders or unexplained excessive bleeding
- History of clinically significant cardiovascular disease or severe symptomatic hypoglycemia within 6 months of screening
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 RO6807952 -
- Primary Outcome Measures
Name Time Method Safety: Incidence of adverse events 8 weeks
- Secondary Outcome Measures
Name Time Method Blood concentrations of RO6807952 8 weeks Effect of RO6807952 on Hemoglobin HbA1c level 8 weeks Effect of RO6807952 on glucose level 8 weeks Change in meal tolerance test 8 weeks