A Multicenter, Randomized, Double-Blind, 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 Anti-Hyperglycemic Therapy

Hoffmann-La Roche0 sites196 target enrollmentNovember 2012

ConditionsDiabetes Mellitus Type 2

InterventionsPlacebo aleglitazar

DrugsPlacebo aleglitazar

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Diabetes Mellitus Type 2
Sponsor: Hoffmann-La Roche
Enrollment: 196
Primary Endpoint: Change from baseline in hemoglobin 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 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.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

September 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 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

Exclusion Criteria

•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

Arms & Interventions

Placebo

Intervention: Placebo

aleglitazar

Intervention: aleglitazar

Outcomes

Primary Outcomes

Change from baseline in hemoglobin HbA1c

Time Frame: From baseline to week 26

Secondary Outcomes

Safety: incidence of adverse events(30 weeks (26 weeks treatment and 4 weeks follow-up))
Change in lipid profile(From baseline to week 26)
Change from baseline in fasting plasma glucose(From baseline to week 26)
Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%)(From baseline to week 26)
Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)(From baseline to week 26)
Change from baseline in homeostatic index of beta cell function (HOMA-BCF)(From baseline to week 26)