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

NCT01043029 | Completed Phase 2

• 2 other identifiers: BC224192009-012270-12
• Study Type: interventional
• Target: 302
• Locations: 13 countries
• Sites: 80

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Renal function: estimated glomerular filtration rate

  Week 60

Secondary Outcomes (3)

• Safety, Tolerability: Adverse events (AEs), laboratory parameters

  AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60

• Renal function: estimated glomerular filtration rate

  Week 52

• Effect on blood hemoglobin

  Week 52

Study Arms (2)

aleglitazar

EXPERIMENTAL

Drug: aleglitazar

pioglitazone

ACTIVE COMPARATOR

Drug: pioglitazone

Interventions

aleglitazar DRUG

Aleglitazar 150 mcg po daily for 52 weeks

aleglitazar

pioglitazone DRUG

Pioglitazone 45 mg po daily for 52 weeks

pioglitazone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (80)

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Camperdown, New South Wales, 2050, Australia

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St Leonards, New South Wales, 2065, Australia

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Brisbane, Queensland, 4075, Australia

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Elizabeth Vale, South Australia, 5112, Australia

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Richmond, South Australia, 3121, Australia

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Launceston, Tasmania, 7001, Australia

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Melbourne, Victoria, 3004, Australia

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Fortaleza, Ceará, 60135-170, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-170, Brazil

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São Paulo, São Paulo, 01221-020, Brazil

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São Paulo, São Paulo, 04022-001, Brazil

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São Paulo, São Paulo, 04231-030, Brazil

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Barranquilla, Colombia

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Bogotá, Colombia

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Bucaramanga, Colombia

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Medellin-Antioquia, Colombia

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San Salvador, El Salvador

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Aschaffenburg, 63739, Germany

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Berlin, 10115, Germany

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Damme, 49401, Germany

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Dresden, 01307, Germany

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Essen, 45359, Germany

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Falkensee, 14612, Germany

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Mainz, 55116, Germany

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Münster, 48145, Germany

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Neuwied, 56564, Germany

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Reichenbach, 08468, Germany

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Rostock, 18059, Germany

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Sulzbach-Rosenberg, 92237, Germany

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Würzburg, 97072, Germany

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Hong Kong, Hong Kong

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Tuenmen, 852, Hong Kong

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Baja, 6500, Hungary

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Budapest, 1036, Hungary

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Budapest, 1045, Hungary

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Budapest, 1135, Hungary

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Debrecen, 4032, Hungary

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Kecskemét, 6001, Hungary

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Miskolc, 3526, Hungary

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Sátoraljaújhely, 3980, Hungary

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Szeged, 6720, Hungary

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Szekszárd, 7100, Hungary

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Genoa, Liguria, 16132, Italy

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Bergamo, Lombardy, 20128, Italy

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Cusano Milanino, Lombardy, 20095, Italy

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Milan, Lombardy, 20132, Italy

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Pavia, Lombardy, 27100, Italy

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Aguascaliente, 20230, Mexico

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Chihuahua City, 31238, Mexico

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Cuernavaca, 62250, Mexico

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Durango, 34080, Mexico

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Guadalajara, 44600, Mexico

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Guadalajara, 44650, Mexico

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Pachuca, 42060, Mexico

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Pachuca, 42090, Mexico

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Arequipa, Cercado, Peru

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Lima, 11, Peru

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Lima, LIMA 29, Peru

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Bucharest, 020475, Romania

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Cluj-Napoca, 400006, Romania

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Iași, 700 503, Romania

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Ploieşti, 100163, Romania

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Sibiu, 550245, Romania

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Târgu Mureş, 540142, Romania

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Chelyabinsk, 454047, Russia

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Moscow, 119121, Russia

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Moscow, 121069, Russia

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Moscow, 125101, Russia

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Moscow, 127299, Russia

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Moscow, 129110, Russia

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Saint Petersburg, 194156, Russia

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Saint Petersburg, 195067, Russia

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Saint Petersburg, 195257, Russia

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Saint Petersburg, 197089, Russia

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Saratov, 140018, Russia

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Yaroslavl, 150062, Russia

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Bratislava, 821 02, Slovakia

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Dolný Kubín, 026 01, Slovakia

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Levice, 034 01, Slovakia

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Lučenec, 984 01, Slovakia

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Related Publications (1)

• Ruilope L, Hanefeld M, Lincoff AM, Viberti G, Meyer-Reigner S, Mudie N, Wieczorek Kirk D, Malmberg K, Herz M. Effects of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on renal function in patients with stage 3 chronic kidney disease and type 2 diabetes: a Phase IIb, randomized study. BMC Nephrol. 2014 Nov 18;15:180. doi: 10.1186/1471-2369-15-180.

  PMID: 25407798 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

aleglitazar; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 6, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

SL (4); HK (2); AU (7); BR (5); ME (8); IT (5); PE (3); EL (1); RU (12); DE (13); CO (4); HU (10); RO (6)