A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy

Roche

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: placebo

Drug: aleglitazar

Study type

Interventional

Funder types

Industry

Identifiers

NCT01871428

YC28037

Details and patient eligibility

About

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes mellitus who are drug-naïve to anti-hyperglycemic therapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patient, >/= 18 years of age
Diagnosis of Type 2 diabetes mellitus within 12 months prior to screening
Drug-naïve (defined as no anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months at any time 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 </= 13.3 mmol/L (</= 240 mg/dL) at pre-randomization visit
Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study

Exclusion criteria

Pregnant women, women intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods
Diagnosis or history of:
1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
Any previous treatment with thiazolidinedione or with a dual peroxisome proliferator activated receptor (PPAR) agonist
Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (>= 1 month) statin therapy
Prior intolerance to fibrate
Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening
Clinically apparent liver disease
Anemia at or within 4 weeks prior to screening
Inadequate renal function
Symptomatic congestive heart failure New York Heart Association (NYHA) Class II-IV at screening
Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening visit
Known macular edema at screening or prior to screening visit
Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
Uncontrolled hypertension
History of active substance abuse (including alcohol) within the past 2 years