Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01043029
First received: January 5, 2010
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: aleglitazar
Drug: pioglitazone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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®

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Renal function: estimated glomerular filtration rate [ Time Frame: Week 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, Tolerability: AEs, laboratory parameters [ Time Frame: AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60 ] [ Designated as safety issue: No ]
  • Renal function: estimated glomerular filtration rate [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Effect on blood hemoglobin [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 302
Study Start Date: May 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: aleglitazar
Aleglitazar 150 mcg po daily for 52 weeks
Active Comparator: 2 Drug: pioglitazone
Pioglitazone 45 mg po daily for 52 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043029

  Hide Study Locations
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
Brazil
Fortaleza, CE, Brazil, 60135-170
Porto Alegre, RS, Brazil, 90035-170
Sao Paulo, SP, Brazil, 04022-001
Sao Paulo, SP, Brazil, 04231-030
Sao Paulo, SP, Brazil, 01221-020
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
Hong Kong, Hong Kong, 852
Hungary
Baja, Hungary, 6500
Budapest, Hungary, 1045
Budapest, Hungary, 1135
Budapest, Hungary, 1036
Debrecen, Hungary, 4032
Kecskemet, Hungary, 6001
Miskolc, Hungary, 3526
Satoraljaujhely, Hungary, 3980
Szeged, Hungary, 6720
Szekszard, Hungary, 7100
Italy
Genova, Liguria, Italy, 16132
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, 42090
Pachuca, Mexico, 42060
Peru
Arequipa, Peru, Cercado
Lima, Peru, LIMA 29
Lima, Peru, 11
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, 127299
Moscow, Russian Federation, 129110
Moscow, Russian Federation, 121069
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 119121
Saint-Petersburg, Russian Federation, 194156
Saratov, Russian Federation, 140018
St Petersburg, Russian Federation, 195257
St Petersburg, Russian Federation, 197089
St Petersburg, Russian Federation, 195067
Yaroslavl, Russian Federation, 150062
Slovakia
Bratislava, Slovakia, 821 02
Dolny Kubin, Slovakia, 026 01
Levice, Slovakia, 034 01
Lucenec, Slovakia, 984 01
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01043029     History of Changes
Other Study ID Numbers: BC22419, 2009-012270-12
Study First Received: January 5, 2010
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 23, 2014