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

July 28, 2016 updated by: Hoffmann-La Roche

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Chihuahua, Mexico, 31238
      • Chihuahua, Mexico, 31328
      • Hermosillo, Mexico, 83067
      • Metepec, Mexico, EMEX52140
      • Mexico City, Mexico, 14000
      • Mexico City, Mexico, 14050
      • Mexico City, Mexico, 11650
      • Monterrey, Mexico, 64000
      • Zapopan, Mexico, 45200
  • Puerto Rico
      • Manati, Puerto Rico, 00674
      • Ponce, Puerto Rico, 00717-322
      • Toa Baja, Puerto Rico, 00949
  • Russian Federation
      • Moscow, Russian Federation, 125101
      • Moscow, Russian Federation, 129110
      • Moscow, Russian Federation, 109472
      • Moscow, Russian Federation, 127299
      • Moscow, Russian Federation, 127486
      • Saratov, Russian Federation, 410038
      • St Petersburg, Russian Federation, 191025
      • St Petersburg, Russian Federation, 197198
      • St Petersburg, Russian Federation, 198205
      • St. Petersburg, Russian Federation, 199106
      • Tumen, Russian Federation, 625023
      • Yaroslavl, Russian Federation, 150062
  • Ukraine
      • Dnipropetrovs'k, Ukraine, 49005
      • Dnipropetrovs'k, Ukraine, 49060
      • Donetsk, Ukraine, 83003
      • Donetsk, Ukraine, 83114
      • Kharkiv, Ukraine, 61039
      • Kharkov, Ukraine, 61178
      • Kiev, Ukraine, 02091
      • Kiev, Ukraine, 2091
      • Kiev, Ukraine, 2125
      • Lugnansk, Ukraine, 91045
      • Poltava, Ukraine, 36024
      • Ternopil, Ukraine, 46002
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
    • California
      • Fresno, California, United States, 93720
      • Los Gatos, California, United States, 95032
      • Mission Viejo, California, United States, 92691
    • Florida
      • Jacksonville, Florida, United States, 32216-4313
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
    • Ohio
      • Marion, Ohio, United States, 43302
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
    • Texas
      • Arlington, Texas, United States, 76017
      • Arlington, Texas, United States, 76014
      • Dallas, Texas, United States, 75231
      • Midland, Texas, United States, 79707
      • San Antonio, Texas, United States, 78284
    • Virginia
      • Norfolk, Virginia, United States, 23510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aleglitazar
Drug: aleglitazar
0.6mg po daily
Active Comparator: Actos
Drug: Actos
45mg po daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relative change from baseline in glomerular filtration rate
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR)
Time Frame: 26 weeks
26 weeks
Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI).
Time Frame: End of treatment
End of treatment
Adverse events (AEs), laboratory parameters.
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

April 16, 2007

First Submitted That Met QC Criteria

April 16, 2007

First Posted (Estimate)

April 17, 2007

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC20653

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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