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

Roche

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: aleglitazar

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01691755

BC28034

Details and patient eligibility

About

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.

Enrollment

196 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
Fasting plasma glucose </=240 mg/dL at pre-randomization visit
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