Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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/study/NCT00663260




Registration number
NCT00663260
Ethics application status
Date submitted
18/04/2008
Date registered
22/04/2008
Date last updated
10/02/2017

Titles & IDs
Public title
Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment
Scientific title
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control
Secondary ID [1] 0 0
MB102-029
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 - Dapagliflozin
Treatment: Drugs - Dapagliflozin
Treatment: Drugs - Placebo

Active comparator: Dapagliflozin (10 mg) -

Active comparator: Dapagliflozin (5 mg) -

Placebo comparator: Placebo -


Treatment: Drugs: Dapagliflozin
Tablets, Oral, 10 mg, Once Daily, 104 weeks

Treatment: Drugs: Dapagliflozin
Tablets, Oral, 5 mg, Once Daily, 104 weeks

Treatment: Drugs: Placebo
Tablets, Oral, 0 mg, Once Daily, 104 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]
Timepoint [1] 0 0
From Baseline to Week 24
Secondary outcome [1] 0 0
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
Timepoint [1] 0 0
From Baseline to Week 24
Secondary outcome [2] 0 0
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
Timepoint [2] 0 0
From Baseline to Week 24

Eligibility
Key inclusion criteria
* Males and females, =18 years old, with type 2 diabetes and with inadequate glycemic control
* Clinical diagnosis of moderate renal impairment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* AST and /or ALT > 3.0 times the upper limit of normal
* Serum total bilirubin > 1.5 times ULN
* Symptoms of severely uncontrolled diabetes
* Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

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
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
631
Recruitment in Australia
Recruitment state(s)
NSW,TAS
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - St Leonards
Recruitment hospital [3] 0 0
Local Institution - Woollongong
Recruitment hospital [4] 0 0
Local Institution - Launceston
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2500 - Woollongong
Recruitment postcode(s) [4] 0 0
7250 - Launceston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Argentina
State/province [20] 0 0
Buenos Aires
Country [21] 0 0
Argentina
State/province [21] 0 0
Cordoba
Country [22] 0 0
Argentina
State/province [22] 0 0
Salta
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
Manitoba
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Canada
State/province [27] 0 0
Saskatchewan
Country [28] 0 0
Denmark
State/province [28] 0 0
Copenhagen Nv
Country [29] 0 0
Denmark
State/province [29] 0 0
Gentofte
Country [30] 0 0
Denmark
State/province [30] 0 0
Hvidovre
Country [31] 0 0
France
State/province [31] 0 0
Besancon Cedex
Country [32] 0 0
France
State/province [32] 0 0
Brest Cedex
Country [33] 0 0
France
State/province [33] 0 0
Paris Cedex 10
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Poitiers Cedex
Country [36] 0 0
India
State/province [36] 0 0
Madhya Pradesh
Country [37] 0 0
India
State/province [37] 0 0
Maharashtra
Country [38] 0 0
India
State/province [38] 0 0
Bangalore
Country [39] 0 0
India
State/province [39] 0 0
Chennai
Country [40] 0 0
India
State/province [40] 0 0
Pune, Maharashtra
Country [41] 0 0
India
State/province [41] 0 0
Rajasthan
Country [42] 0 0
Italy
State/province [42] 0 0
Chieri
Country [43] 0 0
Italy
State/province [43] 0 0
Chieti Scalo
Country [44] 0 0
Italy
State/province [44] 0 0
Modena
Country [45] 0 0
Italy
State/province [45] 0 0
Padova
Country [46] 0 0
Italy
State/province [46] 0 0
Perugia
Country [47] 0 0
Italy
State/province [47] 0 0
Pisa
Country [48] 0 0
Italy
State/province [48] 0 0
Roma
Country [49] 0 0
Italy
State/province [49] 0 0
Siena
Country [50] 0 0
Mexico
State/province [50] 0 0
Distrito Federal
Country [51] 0 0
Mexico
State/province [51] 0 0
Guanajuato
Country [52] 0 0
Mexico
State/province [52] 0 0
Jalisco
Country [53] 0 0
Mexico
State/province [53] 0 0
Nuevo Leon
Country [54] 0 0
Mexico
State/province [54] 0 0
Durango
Country [55] 0 0
Peru
State/province [55] 0 0
Lima
Country [56] 0 0
Peru
State/province [56] 0 0
Arequipa
Country [57] 0 0
Puerto Rico
State/province [57] 0 0
Caguas
Country [58] 0 0
Puerto Rico
State/province [58] 0 0
San Juan
Country [59] 0 0
Singapore
State/province [59] 0 0
Singapore
Country [60] 0 0
Spain
State/province [60] 0 0
Barcelona
Country [61] 0 0
Spain
State/province [61] 0 0
San Sebastian De Los
Country [62] 0 0
Spain
State/province [62] 0 0
Vizcaya

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment
Trial website
https://clinicaltrials.gov/study/NCT00663260
Trial related presentations / publications
Fioretto P, Stefansson BV, Johnsson E, Cain VA, Sjostrom CD. Dapagliflozin reduces albuminuria over 2 years in patients with type 2 diabetes mellitus and renal impairment. Diabetologia. 2016 Sep;59(9):2036-9. doi: 10.1007/s00125-016-4017-1. Epub 2016 Jun 15. No abstract available.
Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2014 Apr;85(4):962-71. doi: 10.1038/ki.2013.356. Epub 2013 Sep 25.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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/study/NCT00663260