A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO6811135 or placebo daily for 2 weeks, with a follow-up examination 2 to 3 weeks after the last dose of study drug.

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

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Adult patients, 18 to 65 years of age, inclusive

• Type 2 diabetes mellitus according to WHO criteria diagnosed for at least 3 months prior to screening

• On stable dose of metformin for at least 2 months prior to screening

• Fasting plasma glucose during the screening period
• Hemoglobin A1c (HbA1c) levels at screening >/= 6.5% and
• Evidence of insulin secretory capacity at screening

• Body mass index (BMI) 27 to 42 kg/m2, inclusive

• Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol

Exclusion Criteria:

• Type 1 diabetes

• Acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes

• History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia

• Evidence or history of clinically significant diabetic complications such as clinically severe diabetic peripheral neuropathy, clinically significant nephropathy as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy as judged by the investigator

• History of severe symptomatic hypoglycemia (requiring assistances of a third party) within 6 months prior to screening

• History or presence of clinically significant concomitant disease or disorder

• Hemoglobin level below the lower limit of reference range at screening

• Pregnant or lactating women

• History of anaphylaxis or severe systemic hypersensitivity or allergic reactions