A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy

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

Summary

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Hypoglycemic Agents

Criteria

Inclusion Criteria:

• Adult patients, >/=18 years of age

• Diagnosis of diabetes mellitus, type 2 within 12 months prior to screening

• Patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past

• HbA1c >/=7% andpre-randomization visit

• Fasting plasma glucose
• Agreement to maintain diet and exercise habits during the study

Exclusion Criteria:

• Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months

• Any previous treatment with thiazolidinedione or a dual peroxisome proliferator activated receptor (PPAR) agonist

• Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)

• Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening