A Study of Aleglitazar in Patients With Type 2 Diabetes

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388518
• Other study ID #: BM17864
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2006
• Last updated: November 1, 2016
• Start date: November 2006
• Est. completion date: March 2008

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Actos
45mg po daily
• Placebo
po daily
• aleglitazar
Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Greece,  Hong Kong,  Italy,  Mexico,  Romania,  Russian Federation,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline in Hemoglobin A1c (HbA1c)		16 weeks	No
Secondary	Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers.		16 weeks	No
Secondary	Adverse Events (AEs), laboratory parameters.		Throughout study	No