A Study of Aleglitazar in Patients With Type 2 Diabetes

A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00388518

Enrollment

332

Registered

2006-10-17

Start date

2006-11-30

Completion date

2008-03-31

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 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Interventions

DRUGActos

45mg po daily

DRUGPlacebo

po daily

DRUGaleglitazar

Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* adult patients, 18-75 years of age; * type 2 diabetes, diagnosed \>=1 month of screening; * either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at submaximal doses; * HbA1c \<=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.

Exclusion criteria

* type 1 diabetes; * currently or previously treated with insulin, a thiazolidinedione, or a dual Peroxisome Proliferator Activated Receptor (PPAR) agonist; * clinically significant cardiovascular disease; * Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in Hemoglobin A1c (HbA1c)	16 weeks

Secondary

Measure	Time frame
Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers.	16 weeks
Adverse Events (AEs), laboratory parameters.	Throughout study

Countries

Greece, Hong Kong, Italy, Mexico, Romania, Russia, Serbia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026