A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy

Phase 3

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Placebo; Drug: aleglitazar

• Registration Number: NCT01691755
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-25
• Study Start: 2012-11
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-08
• Disposition First Submitted: 2016-08-09
• Disposition First Submitted QC: 2016-08-09
• Last Update Submitted: 2016-08-09
• Disposition First Posted: 2016-08-11
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
aleglitazar	aleglitazar	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in hemoglobin HbA1c	From baseline to week 26

Secondary Outcome Measures

Name	Time	Method
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