A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.

NCT ID: NCT00461006

Last Updated: 2016-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-09-30

Brief Summary

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This 2 arm study will compare the effects of aleglitazar and Actos, added to preexisting oral antihyperglycemic therapy and/or diet and exercise, on renal function in patients with type 2 diabetes, and normal or mildly impaired renal function. Eligible patients will be randomized to receive either aleglitazar 0.6mg p.o. or Actos 45mg p.o. daily. Renal function and efficacy parameters will be assessed at intervals during the treatment period. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aleglitazar

Group Type EXPERIMENTAL

aleglitazar

Intervention Type DRUG

0.6mg po daily

Actos

Group Type ACTIVE_COMPARATOR

Actos

Intervention Type DRUG

45mg po daily

Interventions

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Actos

45mg po daily

Intervention Type DRUG

aleglitazar

0.6mg po daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-75 years of age;
* type 2 diabetes for \>=1 month;
* drug naive, or receiving stable oral antihyperglycemic medication;
* HbA1c 6.5-10.0% at screening.

Exclusion Criteria

* type 1 diabetes;
* current or previous treatment with insulin;
* history of renal disease other than diabetic nephropathy;
* uncontrolled hypertension;
* clinically significant cardiovascular disease;
* Congestive heart failure (CHF) New York Heart Association (NYHA) 3-4.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Peoria, Arizona, United States

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Jonesboro, Arkansas, United States

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Fresno, California, United States

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Los Gatos, California, United States

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Mission Viejo, California, United States

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Jacksonville, Florida, United States

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Omaha, Nebraska, United States

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Charlotte, North Carolina, United States

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Marion, Ohio, United States

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Altoona, Pennsylvania, United States

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Arlington, Texas, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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Chihuahua City, , Mexico

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Chihuahua City, , Mexico

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Hermosillo, , Mexico

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Metepec, , Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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Zapopan, , Mexico

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Manatí, , Puerto Rico

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Ponce, , Puerto Rico

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Toa Baja, , Puerto Rico

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Tyumen, , Russia

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Yaroslavl, , Russia

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Dnipro, , Ukraine

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Dnipro, , Ukraine

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Donetsk, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kiev, , Ukraine

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Kiev, , Ukraine

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Lugnansk, , Ukraine

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Poltava, , Ukraine

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Ternopil, , Ukraine

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Countries

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United States Mexico Puerto Rico Russia Ukraine

Other Identifiers

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BC20653

Identifier Type: -

Identifier Source: org_study_id

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