A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment

November 1, 2016 updated by: Hoffmann-La Roche

Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®

This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

302

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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • St. Leonards, New South Wales, Australia, 2065
    • Queensland
      • Brisbane, Queensland, Australia, 4075
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
      • Richmond, South Australia, Australia, 3121
    • Tasmania
      • Launceston, Tasmania, Australia, 7001
    • Victoria
      • Melbourne, Victoria, Australia, 3004
  • Brazil
    • CE
      • Fortaleza, CE, Brazil, 60135-170
    • RS
      • Porto Alegre, RS, Brazil, 90035-170
    • SP
      • Sao Paulo, SP, Brazil, 01221-020
      • Sao Paulo, SP, Brazil, 04022-001
      • Sao Paulo, SP, Brazil, 04231-030
  • Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
      • Bucaramanga, Colombia
      • Medellin-Antioquia, Colombia
  • El Salvador
      • San Salvador, El Salvador
  • Germany
      • Aschaffenburg, Germany, 63739
      • Berlin, Germany, 10115
      • Damme, Germany, 49401
      • Dresden, Germany, 01307
      • Essen, Germany, 45359
      • Falkensee, Germany, 14612
      • Mainz, Germany, 55116
      • Münster, Germany, 48145
      • Neuwied, Germany, 56564
      • Reichenbach, Germany, 08468
      • Rostock, Germany, 18059
      • Sulzbach-Rosenberg, Germany, 92237
      • Würzburg, Germany, 97072
  • Hong Kong
      • Hong Kong, Hong Kong
      • Tuen Mun, Hong Kong, 852
  • Hungary
      • Baja, Hungary, 6500
      • Budapest, Hungary, 1135
      • Budapest, Hungary, 1036
      • Budapest, Hungary, 1045
      • Debrecen, Hungary, 4032
      • Kecskemet, Hungary, 6001
      • Miskolc, Hungary, 3526
      • Satoraljaujhely, Hungary, 3980
      • Szeged, Hungary, 6720
      • Szekszard, Hungary, 7100
  • Italy
    • Liguria
      • Genova, Liguria, Italy, 16132
    • Lombardia
      • Bergamo, Lombardia, Italy, 20128
      • Cusano Milanino, Lombardia, Italy, 20095
      • Milano, Lombardia, Italy, 20132
      • Pavia, Lombardia, Italy, 27100
  • Mexico
      • Aguascaliente, Mexico, 20230
      • Chihuahua, Mexico, 31238
      • Cuernavaca, Mexico, 62250
      • Durango, Mexico, 34080
      • Guadalajara, Mexico, 44650
      • Guadalajara, Mexico, 44600
      • Pachuca, Mexico, 42060
      • Pachuca, Mexico, 42090
  • Peru
      • Arequipa, Peru, Cercado
      • Lima, Peru, 11
      • Lima, Peru, LIMA 29
  • Romania
      • Bucharest, Romania, 020475
      • Cluj-napoca, Romania, 400006
      • Iasi, Romania, 700 503
      • Ploiesti, Romania, 100163
      • Sibiu, Romania, 550245
      • Targu Mures, Romania, 540142
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454047
      • Moscow, Russian Federation, 125101
      • Moscow, Russian Federation, 129110
      • Moscow, Russian Federation, 127299
      • Moscow, Russian Federation, 119121
      • Moscow, Russian Federation, 121069
      • Saint-Petersburg, Russian Federation, 194156
      • Saratov, Russian Federation, 140018
      • St Petersburg, Russian Federation, 195067
      • St Petersburg, Russian Federation, 197089
      • St Petersburg, Russian Federation, 195257
      • Yaroslavl, Russian Federation, 150062
  • Slovakia
      • Bratislava, Slovakia, 821 02
      • Dolny Kubin, Slovakia, 026 01
      • Levice, Slovakia, 034 01
      • Lucenec, Slovakia, 984 01

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients >/= 18 years of age
  • Diabetes mellitus, Type 2
  • Moderately impaired kidney function
  • Drug naive or up to 2 antihyperglycemic medications at stable dose for over 1 month at screening
  • BMI 25-35

Exclusion Criteria:

  • Current or previous treatment with a thiazolidinedione
  • Current or previous treatment with insulin
  • Treatment with fibrates <3 months prior to screening
  • History of renal disease other than diabetic nephropathy

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
Active Comparator: pioglitazone
Drug: pioglitazone
Pioglitazone 45 mg po daily for 52 weeks
Experimental: aleglitazar
Drug: aleglitazar
Aleglitazar 150 mcg po daily for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Renal function: estimated glomerular filtration rate
Time Frame: Week 60
Week 60

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety, Tolerability: Adverse events (AEs), laboratory parameters
Time Frame: AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60
AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60
Renal function: estimated glomerular filtration rate
Time Frame: Week 52
Week 52
Effect on blood hemoglobin
Time Frame: Week 52
Week 52

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC22419
  • 2009-012270-12

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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