Clinical trial NCT01043029: A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-01-06
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Renal function: estimated glomerular filtration rate
timeFrame: Week 60
Secondary outcomes:
measure: Safety, Tolerability: Adverse events (AEs), laboratory parameters
timeFrame: AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60
measure: Renal function: estimated glomerular filtration rate
timeFrame: Week 52
measure: Effect on blood hemoglobin
timeFrame: Week 52
Other outcomes:
Locations:
city: Camperdown
country: Australia
state: New South Wales
city: St. Leonards
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Elizabeth Vale
country: Australia
state: South Australia
city: Richmond
country: Australia
state: South Australia
city: Launceston
country: Australia
state: Tasmania
city: Melbourne
country: Australia
state: Victoria
city: Fortaleza
country: Brazil
state: CE
city: Porto Alegre
country: Brazil
state: RS
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Barranquilla
country: Colombia
city: Bogota
country: Colombia
city: Bucaramanga
country: Colombia
city: Medellin-Antioquia
country: Colombia
city: San Salvador
country: El Salvador
city: Aschaffenburg
country: Germany
city: Berlin
country: Germany
city: Damme
country: Germany
city: Dresden
country: Germany
city: Essen
country: Germany
city: Falkensee
country: Germany
city: Mainz
country: Germany
city: Münster
country: Germany
city: Neuwied
country: Germany
city: Reichenbach
country: Germany
city: Rostock
country: Germany
city: Sulzbach-Rosenberg
country: Germany
city: Würzburg
country: Germany
city: Hong Kong
country: Hong Kong
city: Tuen Mun
country: Hong Kong
city: Baja
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Kecskemet
country: Hungary
city: Miskolc
country: Hungary
city: Satoraljaujhely
country: Hungary
city: Szeged
country: Hungary
city: Szekszard
country: Hungary
city: Genova
country: Italy
state: Liguria
city: Bergamo
country: Italy
state: Lombardia
city: Cusano Milanino
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Aguascaliente
country: Mexico
city: Chihuahua
country: Mexico
city: Cuernavaca
country: Mexico
city: Durango
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Pachuca
country: Mexico
city: Pachuca
country: Mexico
city: Arequipa
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Bucharest
country: Romania
city: Cluj-napoca
country: Romania
city: Iasi
country: Romania
city: Ploiesti
country: Romania
city: Sibiu
country: Romania
city: Targu Mures
country: Romania
city: Chelyabinsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Bratislava
country: Slovakia
city: Dolny Kubin
country: Slovakia
city: Levice
country: Slovakia
city: Lucenec
country: Slovakia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.