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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01043029




Registration number
NCT01043029
Ethics application status
Date submitted
5/01/2010
Date registered
6/01/2010
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment
Scientific title
Effects of 150 mcg Aleglitazar on Renal Function in Patients With Type 2 Diabetes and Moderate Renal Impairment, as Compared to Actos®
Secondary ID [1] 0 0
2009-012270-12
Secondary ID [2] 0 0
BC22419
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - aleglitazar
Treatment: Drugs - pioglitazone

Experimental: aleglitazar -

Active comparator: pioglitazone -


Treatment: Drugs: aleglitazar
Aleglitazar 150 mcg po daily for 52 weeks

Treatment: Drugs: pioglitazone
Pioglitazone 45 mg po daily for 52 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Renal function: estimated glomerular filtration rate
Timepoint [1] 0 0
Week 60
Secondary outcome [1] 0 0
Safety, Tolerability: Adverse events (AEs), laboratory parameters
Timepoint [1] 0 0
AEs: Throughout study, laboratory assessments: Week 2, 4, 8, 12, 16, 20, 26, 39, 52, 56, 60
Secondary outcome [2] 0 0
Renal function: estimated glomerular filtration rate
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Effect on blood hemoglobin
Timepoint [3] 0 0
Week 52

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2012
Sample size
Target
Accrual to date
Final
302
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- St. Leonards
Recruitment hospital [3] 0 0
- Brisbane
Recruitment hospital [4] 0 0
- Elizabeth Vale
Recruitment hospital [5] 0 0
- Richmond
Recruitment hospital [6] 0 0
- Launceston
Recruitment hospital [7] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
4075 - Brisbane
Recruitment postcode(s) [4] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [5] 0 0
3121 - Richmond
Recruitment postcode(s) [6] 0 0
7001 - Launceston
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
CE
Country [2] 0 0
Brazil
State/province [2] 0 0
RS
Country [3] 0 0
Brazil
State/province [3] 0 0
SP
Country [4] 0 0
Colombia
State/province [4] 0 0
Barranquilla
Country [5] 0 0
Colombia
State/province [5] 0 0
Bogota
Country [6] 0 0
Colombia
State/province [6] 0 0
Bucaramanga
Country [7] 0 0
Colombia
State/province [7] 0 0
Medellin-Antioquia
Country [8] 0 0
El Salvador
State/province [8] 0 0
San Salvador
Country [9] 0 0
Germany
State/province [9] 0 0
Aschaffenburg
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Damme
Country [12] 0 0
Germany
State/province [12] 0 0
Dresden
Country [13] 0 0
Germany
State/province [13] 0 0
Essen
Country [14] 0 0
Germany
State/province [14] 0 0
Falkensee
Country [15] 0 0
Germany
State/province [15] 0 0
Mainz
Country [16] 0 0
Germany
State/province [16] 0 0
Münster
Country [17] 0 0
Germany
State/province [17] 0 0
Neuwied
Country [18] 0 0
Germany
State/province [18] 0 0
Reichenbach
Country [19] 0 0
Germany
State/province [19] 0 0
Rostock
Country [20] 0 0
Germany
State/province [20] 0 0
Sulzbach-Rosenberg
Country [21] 0 0
Germany
State/province [21] 0 0
Würzburg
Country [22] 0 0
Hong Kong
State/province [22] 0 0
Hong Kong
Country [23] 0 0
Hong Kong
State/province [23] 0 0
Tuen Mun
Country [24] 0 0
Hungary
State/province [24] 0 0
Baja
Country [25] 0 0
Hungary
State/province [25] 0 0
Budapest
Country [26] 0 0
Hungary
State/province [26] 0 0
Debrecen
Country [27] 0 0
Hungary
State/province [27] 0 0
Kecskemet
Country [28] 0 0
Hungary
State/province [28] 0 0
Miskolc
Country [29] 0 0
Hungary
State/province [29] 0 0
Satoraljaujhely
Country [30] 0 0
Hungary
State/province [30] 0 0
Szeged
Country [31] 0 0
Hungary
State/province [31] 0 0
Szekszard
Country [32] 0 0
Italy
State/province [32] 0 0
Liguria
Country [33] 0 0
Italy
State/province [33] 0 0
Lombardia
Country [34] 0 0
Mexico
State/province [34] 0 0
Aguascaliente
Country [35] 0 0
Mexico
State/province [35] 0 0
Chihuahua
Country [36] 0 0
Mexico
State/province [36] 0 0
Cuernavaca
Country [37] 0 0
Mexico
State/province [37] 0 0
Durango
Country [38] 0 0
Mexico
State/province [38] 0 0
Guadalajara
Country [39] 0 0
Mexico
State/province [39] 0 0
Pachuca
Country [40] 0 0
Peru
State/province [40] 0 0
Arequipa
Country [41] 0 0
Peru
State/province [41] 0 0
Lima
Country [42] 0 0
Romania
State/province [42] 0 0
Bucharest
Country [43] 0 0
Romania
State/province [43] 0 0
Cluj-napoca
Country [44] 0 0
Romania
State/province [44] 0 0
Iasi
Country [45] 0 0
Romania
State/province [45] 0 0
Ploiesti
Country [46] 0 0
Romania
State/province [46] 0 0
Sibiu
Country [47] 0 0
Romania
State/province [47] 0 0
Targu Mures
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Chelyabinsk
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Moscow
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Saint-Petersburg
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Saratov
Country [52] 0 0
Russian Federation
State/province [52] 0 0
St Petersburg
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Yaroslavl
Country [54] 0 0
Slovakia
State/province [54] 0 0
Bratislava
Country [55] 0 0
Slovakia
State/province [55] 0 0
Dolny Kubin
Country [56] 0 0
Slovakia
State/province [56] 0 0
Levice
Country [57] 0 0
Slovakia
State/province [57] 0 0
Lucenec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01043029