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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01043029
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: aleglitazar Drug: pioglitazone Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®
Study Start Date : May 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Experimental: aleglitazar Drug: aleglitazar
Aleglitazar 150 mcg po daily for 52 weeks

Active Comparator: pioglitazone Drug: pioglitazone
Pioglitazone 45 mg po daily for 52 weeks

Primary Outcome Measures :
  1. Renal function: estimated glomerular filtration rate [ Time Frame: Week 60 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Renal function: estimated glomerular filtration rate [ Time Frame: Week 52 ]
  3. Effect on blood hemoglobin [ Time Frame: Week 52 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01043029

  Hide Study Locations
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
Brisbane, Queensland, Australia, 4075
Australia, South Australia
Elizabeth Vale, South Australia, Australia, 5112
Richmond, South Australia, Australia, 3121
Australia, Tasmania
Launceston, Tasmania, Australia, 7001
Australia, Victoria
Melbourne, Victoria, Australia, 3004
Fortaleza, CE, Brazil, 60135-170
Porto Alegre, RS, Brazil, 90035-170
Sao Paulo, SP, Brazil, 01221-020
Sao Paulo, SP, Brazil, 04022-001
Sao Paulo, SP, Brazil, 04231-030
Barranquilla, Colombia
Bogota, Colombia
Bucaramanga, Colombia
Medellin-Antioquia, Colombia
El Salvador
San Salvador, El Salvador
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
Baja, Hungary, 6500
Budapest, Hungary, 1036
Budapest, Hungary, 1045
Budapest, Hungary, 1135
Debrecen, Hungary, 4032
Kecskemet, Hungary, 6001
Miskolc, Hungary, 3526
Satoraljaujhely, Hungary, 3980
Szeged, Hungary, 6720
Szekszard, Hungary, 7100
Genova, Liguria, Italy, 16132
Bergamo, Lombardia, Italy, 20128
Cusano Milanino, Lombardia, Italy, 20095
Milano, Lombardia, Italy, 20132
Pavia, Lombardia, Italy, 27100
Aguascaliente, Mexico, 20230
Chihuahua, Mexico, 31238
Cuernavaca, Mexico, 62250
Durango, Mexico, 34080
Guadalajara, Mexico, 44600
Guadalajara, Mexico, 44650
Pachuca, Mexico, 42060
Pachuca, Mexico, 42090
Arequipa, Peru, Cercado
Lima, Peru, 11
Lima, Peru, LIMA 29
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, 119121
Moscow, Russian Federation, 121069
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 127299
Moscow, Russian Federation, 129110
Saint-Petersburg, Russian Federation, 194156
Saratov, Russian Federation, 140018
St Petersburg, Russian Federation, 195067
St Petersburg, Russian Federation, 195257
St Petersburg, Russian Federation, 197089
Yaroslavl, Russian Federation, 150062
Bratislava, Slovakia, 821 02
Dolny Kubin, Slovakia, 026 01
Levice, Slovakia, 034 01
Lucenec, Slovakia, 984 01
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT01043029     History of Changes
Other Study ID Numbers: BC22419
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Renal Insufficiency
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs