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Completed

NCT Number: NCT00461006

A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.

This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and efficacy parameters will be assessed at intervals during the treatment period. 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

Chihuahua City, Mexico

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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 for >=1 month;
  • drug naive, or receiving stable oral antihyperglycemic medication;
  • HbA1c 6.5-10.0% at screening.

Exclusion criteria

  • type 1 diabetes;
  • current or previous treatment with insulin;
  • history of renal disease other than diabetic nephropathy;
  • uncontrolled hypertension;
  • clinically significant cardiovascular disease;
  • Congestive heart failure (CHF) New York Heart Association (NYHA) 3-4.

Treatment and study plan

Actos

Drug

45mg po daily

aleglitazar

Drug

0.6mg po daily

Primary outcomes

  1. Relative change from baseline in glomerular filtration rate

    Time frame: 26 weeks

Secondary outcomes

  1. Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR)

    Time frame: 26 weeks

  2. Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI).

    Time frame: End of treatment

  3. 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 Compare the Effects of Aleglitazar and Actos on Glomerular Filtration Rate and Other Parameters of Renal Function in Patients With Type 2 Diabetes.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 17, 2007
Registry last updated
Aug 1, 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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