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

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PHASE III STUDY TO ASSESS THE EFFICACY,SAFETY AND TOLERABILITY OF ALEGLITAZAR ADDED TO A SU OR ADDED TO A SU IN COMBINATION WITH MET IN PATIENTS WITH T2D INADEQUATELY CONTROLLED WITH SU MONOTHERAPY OR WITH SU + METFORMIN COMBINATION THERAPY

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01691989

Enrollment

197

Registered

2012-09-25

Start date

2012-12-31

Completion date

2013-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

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.

Interventions

DRUGaleglitazar

150 mcg orally once a day for 26 weeks

DRUGplacebo

oral doses once a day for 26 weeks

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in hemoglobin HbA1c	From baseline to week 26

Secondary

Measure	Time frame
Change from baseline in fasting plasma glucose	From baseline to week 26
Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%)	From baseline to week 26
Change in lipid profile	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 from baseline in homeostatic index of insulin sensitivity (HOMA-IS)	From baseline to week 26

Countries

Argentina, Colombia, Guatemala, Mexico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026