A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy

Phase 3

Completed

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

• Registration Number: NCT01691989
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar compared with placebo when added to a sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy in patients with type 2 diabetes mellitus who are inadequately controlled with sulfonylurea alone or sulfonylurea plus metformin 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: 2012-12
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

Inclusion Criteria

• Adult patients, >/=18 years of age
• Diagnosis of diabetes mellitus, type 2
• Patients treated with stable sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 12 weeks prior to screening
• 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 PPAR agonist
• Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
• Any anti-hyperglycemic medication other than sulfonylurea alone or in combination with metformin within 12 weeks prior to screening
• 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
aleglitazar	aleglitazar	-
placebo	placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Responder rate as defined of hemoglobin 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 markers of insulin sensitivity and cardiovascular risk	From baseline to week 26
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