A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment
NCT ID: NCT01043029
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
302 participants
INTERVENTIONAL
2010-05-31
2012-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
aleglitazar
aleglitazar
Aleglitazar 150 mcg po daily for 52 weeks
pioglitazone
pioglitazone
Pioglitazone 45 mg po daily for 52 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
aleglitazar
Aleglitazar 150 mcg po daily for 52 weeks
pioglitazone
Pioglitazone 45 mg po daily for 52 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 insulin
* Treatment with fibrates \<3 months prior to screening
* History of renal disease other than diabetic nephropathy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Camperdown, New South Wales, Australia
St Leonards, New South Wales, Australia
Brisbane, Queensland, Australia
Elizabeth Vale, South Australia, Australia
Richmond, South Australia, Australia
Launceston, Tasmania, Australia
Melbourne, Victoria, Australia
Fortaleza, Ceará, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Barranquilla, , Colombia
Bogotá, , Colombia
Bucaramanga, , Colombia
Medellin-Antioquia, , Colombia
San Salvador, , El Salvador
Aschaffenburg, , Germany
Berlin, , Germany
Damme, , Germany
Dresden, , Germany
Essen, , Germany
Falkensee, , Germany
Mainz, , Germany
Münster, , Germany
Neuwied, , Germany
Reichenbach, , Germany
Rostock, , Germany
Sulzbach-Rosenberg, , Germany
Würzburg, , Germany
Hong Kong, , Hong Kong
Tuenmen, , Hong Kong
Baja, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Kecskemét, , Hungary
Miskolc, , Hungary
Sátoraljaújhely, , Hungary
Szeged, , Hungary
Szekszárd, , Hungary
Genoa, Liguria, Italy
Bergamo, Lombardy, Italy
Cusano Milanino, Lombardy, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Aguascaliente, , Mexico
Chihuahua City, , Mexico
Cuernavaca, , Mexico
Durango, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Pachuca, , Mexico
Pachuca, , Mexico
Arequipa, , Peru
Lima, , Peru
Lima, , Peru
Bucharest, , Romania
Cluj-Napoca, , Romania
Iași, , Romania
Ploieşti, , Romania
Sibiu, , Romania
Târgu Mureş, , Romania
Chelyabinsk, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Yaroslavl, , Russia
Bratislava, , Slovakia
Dolný Kubín, , Slovakia
Levice, , Slovakia
Lučenec, , Slovakia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-012270-12
Identifier Type: -
Identifier Source: secondary_id
BC22419
Identifier Type: -
Identifier Source: org_study_id