A Study of RO6807952 in Patients With Diabetes Mellitus Type 2

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Adult patients, 18 to 70 years of age, inclusive

• Diagnosis of type 2 diabetes >/=3 months and
• Fasting plasma glucose >/=110 mg/dL and
• Patients on a stable dose of metformin for at least 2 months prior to screening

• Hemoglobin HbA1c >/=6.5% and
• Body mass index >/=25 kg/m2 and
• Systolic blood pressure <155 mmHg and diastolic blood pressure <95 mmHg

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