Back to resultsA Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Actos
aleglitazar
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- type 2 diabetes for >=1 month;
- drug naive, or receiving stable doses of <=2 oral antihyperglycemic medications;
- HbA1c 6.5-10.0% at screening;
- symptomatic, stable NYHA class 2 heart failure at screening.
Exclusion Criteria:
- type 1 diabetes;
- current or previous treatment with insulin;
- uncontrolled hypertension;
- NYHA class 1, 3 or 4 at screening.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Actos
Aleglitazar
Arm Description
Outcomes
Primary Outcome Measures
Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.
Secondary Outcome Measures
Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters.
Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00461058
Brief Title
A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
Official Title
A Randomized, Double Blind Study to Compare the Safety and Tolerability of Aleglitazar and Actos in Patients With Type 2 Diabetes and NYHA Class II Heart Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (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 safety, tolerability and efficacy of aleglitazar and Actos in patients with type 2 diabetes and symptomatic NYHA class II heart failure. Eligible patients will be randomized to receive either aleglitazar, titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily, or Actos, titrated to an individual maximum tolerated dose up to 45mg p.o. daily, in addition to prescribed diabetes therapy where applicable. 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
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Actos
Arm Type
Active Comparator
Arm Title
Aleglitazar
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Actos
Intervention Description
Titrated to an individual maximum tolerated dose up to 45mg p.o. daily
Intervention Type
Drug
Intervention Name(s)
aleglitazar
Intervention Description
Titrated to an individual maximum tolerated dose up to 0.3mg p.o. daily
Primary Outcome Measure Information:
Title
Incidence of cardiovascular death, hospitalization or clinic visit for heart failure with i.v. administration of diuretics during 26 week treatment period.
Time Frame
26 week
Secondary Outcome Measure Information:
Title
Safety: peripheral oedema, deterioration of heart failure, increase in body weight during 26 week treatment period, adverse events (AEs), laboratory parameters.
Time Frame
26 week
Title
Efficacy: Change from baseline to week 26 in Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), fasting plasma insulin (FPI) and lipid profile.
Time Frame
26 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
type 2 diabetes for >=1 month;
drug naive, or receiving stable doses of <=2 oral antihyperglycemic medications;
HbA1c 6.5-10.0% at screening;
symptomatic, stable NYHA class 2 heart failure at screening.
Exclusion Criteria:
type 1 diabetes;
current or previous treatment with insulin;
uncontrolled hypertension;
NYHA class 1, 3 or 4 at screening.
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
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Culiacan
ZIP/Postal Code
SIN80020
Country
Mexico
City
Guadalajara
ZIP/Postal Code
JAL44340
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
DF7060
Country
Mexico
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
City
Pachuca
ZIP/Postal Code
42000
Country
Mexico
City
San Luis Potosi
ZIP/Postal Code
SLP78250
Country
Mexico
City
Arad
ZIP/Postal Code
310037
Country
Romania
City
Bacau
ZIP/Postal Code
600114
Country
Romania
City
Baia Mare
ZIP/Postal Code
430123
Country
Romania
City
Bucuresti
ZIP/Postal Code
010242
Country
Romania
City
Bucuresti
ZIP/Postal Code
20475
Country
Romania
City
Bucuresti
ZIP/Postal Code
50452
Country
Romania
City
Oradea
ZIP/Postal Code
410169
Country
Romania
City
Ploiesti
ZIP/Postal Code
100097
Country
Romania
City
Targoviste
ZIP/Postal Code
130083
Country
Romania
City
Moscow
ZIP/Postal Code
123436
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
City
Moscow
ZIP/Postal Code
127018
Country
Russian Federation
City
Moscow
ZIP/Postal Code
127299
Country
Russian Federation
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
City
Donetsk
ZIP/Postal Code
83003
Country
Ukraine
City
Donetsk
ZIP/Postal Code
83114
Country
Ukraine
City
Kharkov
ZIP/Postal Code
61178
Country
Ukraine
City
Kiev
ZIP/Postal Code
02091
Country
Ukraine
City
Kiev
ZIP/Postal Code
1151
Country
Ukraine
City
Kiev
ZIP/Postal Code
2091
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
A Comparative Study of Aleglitazar and Actos in Patients With Type 2 Diabetes Mellitus and New York Heart Association (NYHA) Class II Heart Failure.
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