Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
MB102-029
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
0
0
Query!
Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]
Query!
Assessment method [1]
0
0
HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period.
Query!
Timepoint [1]
0
0
From Baseline to Week 24
Query!
Secondary outcome [1]
0
0
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
Query!
Assessment method [1]
0
0
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period
Query!
Timepoint [1]
0
0
From Baseline to Week 24
Query!
Secondary outcome [2]
0
0
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
Query!
Assessment method [2]
0
0
Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.
Query!
Timepoint [2]
0
0
From Baseline to Week 24
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2/Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/06/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
631
Query!
Recruitment in Australia
Recruitment state(s)
NSW,TAS
Query!
Recruitment hospital [1]
0
0
Local Institution - Camperdown
Query!
Recruitment hospital [2]
0
0
Local Institution - St Leonards
Query!
Recruitment hospital [3]
0
0
Local Institution - Woollongong
Query!
Recruitment hospital [4]
0
0
Local Institution - Launceston
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [3]
0
0
2500 - Woollongong
Query!
Recruitment postcode(s) [4]
0
0
7250 - Launceston
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Minnesota
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Missouri
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Nebraska
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Jersey
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Oklahoma
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Oregon
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Pennsylvania
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
South Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Texas
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Virginia
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Washington
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Wisconsin
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
Buenos Aires
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Cordoba
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Salta
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Alberta
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Manitoba
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Ontario
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Quebec
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Saskatchewan
Query!
Country [28]
0
0
Denmark
Query!
State/province [28]
0
0
Copenhagen Nv
Query!
Country [29]
0
0
Denmark
Query!
State/province [29]
0
0
Gentofte
Query!
Country [30]
0
0
Denmark
Query!
State/province [30]
0
0
Hvidovre
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Besancon Cedex
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Brest Cedex
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Paris Cedex 10
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Paris
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Poitiers Cedex
Query!
Country [36]
0
0
India
Query!
State/province [36]
0
0
Madhya Pradesh
Query!
Country [37]
0
0
India
Query!
State/province [37]
0
0
Maharashtra
Query!
Country [38]
0
0
India
Query!
State/province [38]
0
0
Bangalore
Query!
Country [39]
0
0
India
Query!
State/province [39]
0
0
Chennai
Query!
Country [40]
0
0
India
Query!
State/province [40]
0
0
Pune, Maharashtra
Query!
Country [41]
0
0
India
Query!
State/province [41]
0
0
Rajasthan
Query!
Country [42]
0
0
Italy
Query!
State/province [42]
0
0
Chieri
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Chieti Scalo
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Modena
Query!
Country [45]
0
0
Italy
Query!
State/province [45]
0
0
Padova
Query!
Country [46]
0
0
Italy
Query!
State/province [46]
0
0
Perugia
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Pisa
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Roma
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Siena
Query!
Country [50]
0
0
Mexico
Query!
State/province [50]
0
0
Distrito Federal
Query!
Country [51]
0
0
Mexico
Query!
State/province [51]
0
0
Guanajuato
Query!
Country [52]
0
0
Mexico
Query!
State/province [52]
0
0
Jalisco
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
Nuevo Leon
Query!
Country [54]
0
0
Mexico
Query!
State/province [54]
0
0
Durango
Query!
Country [55]
0
0
Peru
Query!
State/province [55]
0
0
Lima
Query!
Country [56]
0
0
Peru
Query!
State/province [56]
0
0
Arequipa
Query!
Country [57]
0
0
Puerto Rico
Query!
State/province [57]
0
0
Caguas
Query!
Country [58]
0
0
Puerto Rico
Query!
State/province [58]
0
0
San Juan
Query!
Country [59]
0
0
Singapore
Query!
State/province [59]
0
0
Singapore
Query!
Country [60]
0
0
Spain
Query!
State/province [60]
0
0
Barcelona
Query!
Country [61]
0
0
Spain
Query!
State/province [61]
0
0
San Sebastian De Los
Query!
Country [62]
0
0
Spain
Query!
State/province [62]
0
0
Vizcaya
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Bristol-Myers Squibb
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00663260
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00663260
Download to PDF