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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT01691755

Run by

Hoffmann-La Roche

People needed

196

Starts

2012-11-01

Expected to finish

2013-09-01

Last updated by the study team

2016-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Chino, California, United States
• Study site — Los Angeles, California, United States
• Study site — Santa Ana, California, United States
• Study site — Thousand Oaks, California, United States
• Study site — Upland, California, United States
• Study site — West Hills, California, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Cooper City, Florida, United States
• Study site — Coral Gables, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Avon, Indiana, United States
• Study site — City of Saint Peters, Missouri, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Altoona, Pennsylvania, United States
• Study site — Scranton, Pennsylvania, United States
• Study site — Tipton, Pennsylvania, United States
• Study site — Greer, South Carolina, United States
• Study site — Knoxville, Tennessee, United States
• Study site — Spokane, Washington, United States
• Study site — Aguascaliente, Mexico
• Study site — Cuernavaca, Mexico

Full record on ClinicalTrials.gov

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