A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin

Roche

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: metformin

Drug: placebo

Drug: aleglitazar

Study type

Interventional

Funder types

Industry

Identifiers

NCT01729403

WC28038

Details and patient eligibility

About

This single-center, randomized, double-blind, placebo-controlled study will evaluate the effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who are inadequately controlled on metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg or placebo orally daily for 16 weeks, in addition to their existing dose and regimen of metformin.

Enrollment

57 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients, 30 to 70 years of age inclusive at screening
Type 2 diabetes mellitus patients treated with stable metformin therapy for at least 12 weeks prior to screening; metformin dose should not exceed the maximum dose specified in the label
HbA1c >/= 6.5% and </= 9% at screening and baseline
Fasting plasma glucose </= 13.3 mmol/L (</= 240 mg/dl) at screening and baseline
Body mass index (BMI) >/= 25 at screening; BMI >/= 27 for subjects with HbA1c < 7%
Stable weight +/- 5% for at least 12 weeks prior to screening

Exclusion criteria

Women who are pregnant, 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 type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
Any previous treatment with a 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
History of bariatric surgery or currently undergoing evaluation for bariatric surgery
Prior intolerance to fibrate
Treatment with any anti-diabetic medication other than metformin in the last 12 weeks prior to screening and/or herbal/over-the-counter preparations that may affect glycemic control within 12 weeks prior to screening
Clinically apparent liver disease
Positive for hepatitis B, hepatitis C or HIV infection
Clinical evidence of anemia
Symptomatic congestive heart failure (New York Heart Association Class II-IV) at screening
Myocardial infarction, acute coronary syndrome, or transient ischemic attack/stroke within 6 months prior to screening
Known macular edema at screening or prior to screening visit
Uncontrolled hypertension despite stable (for at least 4 weeks) anti-hypertensive treatment
Diagnosed and/or treated malignancy (except for treated cases of basal cell skin cancer, in situ carcinoma of the cervix or in situ prostate cancer) within the past 5 years
Chronic oral or parenteral corticosteroid treatment (> 2 weeks) within 3 months prior to screening
History of active substance abuse (including alcohol) within the past 2 years or positive test result for drugs of abuse or alcohol prior to first dosing
Presence of any absolute or relative contraindication for the conduct of magnetic resonance imaging (MRI) investigation