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

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Actos
aleglitazar
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aleglitazar

Actos

Arm Description

Outcomes

Primary Outcome Measures

Relative change from baseline in glomerular filtration rate

Secondary Outcome Measures

Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR)
Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI).
Adverse events (AEs), laboratory parameters.

Full Information

First Posted
April 16, 2007
Last Updated
July 28, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00461006
Brief Title
A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes.
Official Title
A Randomized, Double Blind Study to Compare the Effects of Aleglitazar and Actos on Glomerular Filtration Rate and Other Parameters of Renal Function in Patients With Type 2 Diabetes.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aleglitazar
Arm Type
Experimental
Arm Title
Actos
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Actos
Intervention Description
45mg po daily
Intervention Type
Drug
Intervention Name(s)
aleglitazar
Intervention Description
0.6mg po daily
Primary Outcome Measure Information:
Title
Relative change from baseline in glomerular filtration rate
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Relative change from baseline in estimated renal plasma flow (ERPF) and urine albumin-creatinine ratio (UACR)
Time Frame
26 weeks
Title
Absolute change in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and fasting plasma insulin (FPI).
Time Frame
End of treatment
Title
Adverse events (AEs), laboratory parameters.
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216-4313
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76017
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Midland
State/Province
Texas
ZIP/Postal Code
79707
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
City
Chihuahua
ZIP/Postal Code
31328
Country
Mexico
City
Hermosillo
ZIP/Postal Code
83067
Country
Mexico
City
Metepec
ZIP/Postal Code
EMEX52140
Country
Mexico
City
Mexico City
ZIP/Postal Code
11650
Country
Mexico
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
City
Zapopan
ZIP/Postal Code
45200
Country
Mexico
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
City
Ponce
ZIP/Postal Code
00717-322
Country
Puerto Rico
City
Toa Baja
ZIP/Postal Code
00949
Country
Puerto Rico
City
Moscow
ZIP/Postal Code
109472
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
City
Moscow
ZIP/Postal Code
127299
Country
Russian Federation
City
Moscow
ZIP/Postal Code
127486
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
City
Saratov
ZIP/Postal Code
410038
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197198
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
City
Tumen
ZIP/Postal Code
625023
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
City
Dnipropetrovs'k
ZIP/Postal Code
49005
Country
Ukraine
City
Dnipropetrovs'k
ZIP/Postal Code
49060
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83003
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83114
Country
Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
City
Kharkov
ZIP/Postal Code
61178
Country
Ukraine
City
Kiev
ZIP/Postal Code
02091
Country
Ukraine
City
Kiev
ZIP/Postal Code
2091
Country
Ukraine
City
Kiev
ZIP/Postal Code
2125
Country
Ukraine
City
Lugnansk
ZIP/Postal Code
91045
Country
Ukraine
City
Poltava
ZIP/Postal Code
36024
Country
Ukraine
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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