Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
This multi-center, randomized, double-blind, active controlled, parallel-group study in type
2 diabetes patients with moderate renal impairment will evaluate the effect on renal function
and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be
randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses.
In addition, a diet and exercise plan will also be implemented during the anticipated time on
study treatment of 52 weeks. The target sample size is 200-400 patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01043029
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01043029