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OpenTrials
Completed

NCT Number: NCT00388518

A Study of Aleglitazar in Patients With Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Athens, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Actos

Drug

45mg po daily

Placebo

Drug

po daily

aleglitazar

Drug

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

Primary outcomes

  1. Absolute change from baseline in Hemoglobin A1c (HbA1c)

    Time frame: 16 weeks

Secondary outcomes

  1. Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers.

    Time frame: 16 weeks

  2. Adverse Events (AEs), laboratory parameters.

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 17, 2006
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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