A Multicenter, Randomized, Doubleblind, Placebo-Controlled, Phase III Study to Assess the Efficacy, Safety and Tolerability of Aleglitazar Monotherapy Compared With Placebo in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Drug-Naïve to Antihyperglycemic Therapy

Hoffmann-La Roche0 sites13 target enrollmentJune 2013

ConditionsDiabetes Mellitus Type 2

Interventionsaleglitazar placebo

Drugsaleglitazar placebo

Overview

Phase: Phase 3
Intervention: aleglitazar
Conditions: Diabetes Mellitus Type 2
Sponsor: Hoffmann-La Roche
Enrollment: 13
Primary Endpoint: Change in HbA1c
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

November 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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:
•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 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

Arms & Interventions

Aleglitazar

Intervention: aleglitazar

Placebo

Intervention: placebo

Outcomes

Primary Outcomes

Change in HbA1c

Time Frame: from baseline to Week 26

Secondary Outcomes

Change in lipids(from baseline to Week 26)
Change in fasting plasma glucose (FPG)(from baseline to Week 26)
Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26(26 weeks)
Change in homeostatic index of insulin sensitivity (by Homeostasis Model Assessment for Insulin Sensitivity [HOMA-IS])(from baseline to Week 26)
Change in homeostatic index of beta cell function (by HOMA-BFC)(from baseline to Week 26)
Change in markers of insulin sensitivity/cardiovascular risk(from baseline to Week 26)
Safety: Incidence of adverse events(approximately 30 weeks)