A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin 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 compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin 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

NCT01691989

Run by

Hoffmann-La Roche

People needed

197

Starts

2012-12-01

Expected to finish

2013-09-01

Last updated by the study team

2016-11-02

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
• Patients treated with stable sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 12 weeks prior to screening
• 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 PPAR agonist
• Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
• Any anti-hyperglycemic medication other than sulfonylurea alone or in combination with metformin within 12 weeks prior to screening
• 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 — San Diego, California, United States
• Study site — Santa Ana, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Avon, Indiana, United States
• Study site — Bethesda, Maryland, United States
• Study site — Durham, North Carolina, United States
• Study site — Morrisville, Pennsylvania, United States
• Study site — Greer, South Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Buenos Aires, Argentina
• Study site — Caba, Argentina
• Study site — Rosario, Argentina
• Study site — Bogotá, Colombia
• Study site — Floridablanca, Colombia
• Study site — Medellin-Antioquia, Colombia
• Study site — Guatemala City, Guatemala
• Study site — Guatemala City, Guatemala
• Study site — Aguascaliente, Mexico
• Study site — Celaya, Mexico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.