Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT02268214




Registration number
NCT02268214
Ethics application status
Date submitted
15/10/2014
Date registered
20/10/2014
Date last updated
13/09/2018

Titles & IDs
Public title
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus
Secondary ID [1] 0 0
2013-004674-97
Secondary ID [2] 0 0
MB102-229
Universal Trial Number (UTN)
Trial acronym
DEPICT 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 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 - Placebo for dapagliflozin

Experimental: Arm A: Dapagliflozin - Dapagliflozin 5 mg tablet orally, once daily for 52 weeks

Experimental: Arm B: Dapagliflozin - Dapagliflozin 10 mg tablet orally, once daily for 52 weeks

Placebo comparator: Arm C: Placebo for Dapagliflozin - Placebo tablet orally, once daily for 52 weeks


Treatment: Drugs: Dapagliflozin
Tablets

Treatment: Drugs: Placebo for dapagliflozin
Tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjusted Mean Change in HbA1c From Baseline at Week 24
Timepoint [1] 0 0
From Baseline to Week 24
Secondary outcome [1] 0 0
Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24
Timepoint [1] 0 0
From Baseline to Week 24
Secondary outcome [2] 0 0
Adjusted Mean Percent Change in Body Weight From Baseline at Week 24
Timepoint [2] 0 0
From Baseline to Week 24
Secondary outcome [3] 0 0
Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24
Timepoint [3] 0 0
From Baseline to Week 24
Secondary outcome [4] 0 0
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24
Timepoint [4] 0 0
From Baseline to Week 24
Secondary outcome [5] 0 0
Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24
Timepoint [5] 0 0
From Baseline to Week 24
Secondary outcome [6] 0 0
Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events
Timepoint [6] 0 0
From Baseline to Week 24

Eligibility
Key inclusion criteria
* Diagnosis of Type 1 Diabetes mellitus (T1DM)
* Central laboratory C-peptide < 0.7 ng/ml (0.23 nmol/L)
* Insulin use for at least 12 months per patient reported or medical records
* Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to screening
* Subjects must be on a total insulin dose of = 0.3 U/kg/day for at least 3 months prior to screening
* If on MDI insulin administration, subject must be on = 3x injections per day
* Screening Visit: Central laboratory HbA1c = 7.7% and = 11.0%
* Body mass index (BMI) = 18.5 kg/m2
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of Type 2 Diabetes mellitus (T2DM) or maturity onset diabetes of the young (MODY), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity
* Taking metformin and/or thiazolidinediones within 2 months prior to screening
* Taking any antidiabetic medication (other than insulin), within 1 month prior to screening

- Taking GLP-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration
* History of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening
* History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening
* Frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening
* History of Addison's disease

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
11/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/08/2017
Sample size
Target
Accrual to date
Final
833
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Concord
Recruitment hospital [2] 0 0
Research Site - Daw Park
Recruitment hospital [3] 0 0
Research Site - Fitzroy
Recruitment hospital [4] 0 0
Research Site - Heidelberg West
Recruitment hospital [5] 0 0
Research Site - Newcastle
Recruitment hospital [6] 0 0
Research Site - Southport
Recruitment hospital [7] 0 0
Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
5041 - Daw Park
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [5] 0 0
2291 - Newcastle
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maine
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Austria
State/province [21] 0 0
Innsbruck
Country [22] 0 0
Austria
State/province [22] 0 0
Saint Stefan/Stainz
Country [23] 0 0
Austria
State/province [23] 0 0
Wien
Country [24] 0 0
Belgium
State/province [24] 0 0
Bonheiden
Country [25] 0 0
Belgium
State/province [25] 0 0
Leuven
Country [26] 0 0
Belgium
State/province [26] 0 0
Liege
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Manitoba
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Denmark
State/province [31] 0 0
Arhus C
Country [32] 0 0
Denmark
State/province [32] 0 0
Esbjerg
Country [33] 0 0
Denmark
State/province [33] 0 0
Odense
Country [34] 0 0
Denmark
State/province [34] 0 0
Randers NØ
Country [35] 0 0
Finland
State/province [35] 0 0
Helsinki
Country [36] 0 0
Finland
State/province [36] 0 0
Jyvaskyla
Country [37] 0 0
Finland
State/province [37] 0 0
Kuopio
Country [38] 0 0
Finland
State/province [38] 0 0
Oulu
Country [39] 0 0
Finland
State/province [39] 0 0
Tampere
Country [40] 0 0
France
State/province [40] 0 0
Besançon Cedex
Country [41] 0 0
France
State/province [41] 0 0
Corbeil-Essonnes
Country [42] 0 0
France
State/province [42] 0 0
Dijon
Country [43] 0 0
France
State/province [43] 0 0
SAINT HERBLAIN Cedex
Country [44] 0 0
France
State/province [44] 0 0
Vandoeuvre les Nancy
Country [45] 0 0
Germany
State/province [45] 0 0
Aschaffenburg
Country [46] 0 0
Germany
State/province [46] 0 0
Aßlar
Country [47] 0 0
Germany
State/province [47] 0 0
Bad Oeynhausen
Country [48] 0 0
Germany
State/province [48] 0 0
Falkensee
Country [49] 0 0
Germany
State/province [49] 0 0
Munich
Country [50] 0 0
Germany
State/province [50] 0 0
Munster
Country [51] 0 0
Germany
State/province [51] 0 0
Neuwied
Country [52] 0 0
Germany
State/province [52] 0 0
Oldenburg
Country [53] 0 0
Germany
State/province [53] 0 0
Pohlheim
Country [54] 0 0
Germany
State/province [54] 0 0
Schweinfurt
Country [55] 0 0
Germany
State/province [55] 0 0
Sulzbach
Country [56] 0 0
Germany
State/province [56] 0 0
Witten
Country [57] 0 0
Hungary
State/province [57] 0 0
Baja
Country [58] 0 0
Hungary
State/province [58] 0 0
Balatonfured
Country [59] 0 0
Hungary
State/province [59] 0 0
Budapest
Country [60] 0 0
Hungary
State/province [60] 0 0
Létavértes
Country [61] 0 0
Hungary
State/province [61] 0 0
Szeged
Country [62] 0 0
Hungary
State/province [62] 0 0
Zalaegerszeg
Country [63] 0 0
Israel
State/province [63] 0 0
Haifa
Country [64] 0 0
Israel
State/province [64] 0 0
Jerusalem
Country [65] 0 0
Israel
State/province [65] 0 0
Safed
Country [66] 0 0
Israel
State/province [66] 0 0
Tel-Aviv
Country [67] 0 0
Israel
State/province [67] 0 0
Tikva
Country [68] 0 0
Italy
State/province [68] 0 0
Firenze
Country [69] 0 0
Italy
State/province [69] 0 0
Milano
Country [70] 0 0
Italy
State/province [70] 0 0
Padowa
Country [71] 0 0
Italy
State/province [71] 0 0
Palermo
Country [72] 0 0
Italy
State/province [72] 0 0
Ravenna
Country [73] 0 0
Italy
State/province [73] 0 0
Sesto San Giovanni
Country [74] 0 0
Italy
State/province [74] 0 0
Siena
Country [75] 0 0
Mexico
State/province [75] 0 0
Aguascalientes
Country [76] 0 0
Mexico
State/province [76] 0 0
Chihuahua
Country [77] 0 0
Mexico
State/province [77] 0 0
Cuernavaca
Country [78] 0 0
Mexico
State/province [78] 0 0
Guadalajara
Country [79] 0 0
Mexico
State/province [79] 0 0
Merida
Country [80] 0 0
Mexico
State/province [80] 0 0
Mexico
Country [81] 0 0
Mexico
State/province [81] 0 0
Monterrey
Country [82] 0 0
Mexico
State/province [82] 0 0
Torreon
Country [83] 0 0
Mexico
State/province [83] 0 0
Zapopan, Jalisco
Country [84] 0 0
Mexico
State/province [84] 0 0
Zapopan
Country [85] 0 0
Romania
State/province [85] 0 0
Bucuresti
Country [86] 0 0
Romania
State/province [86] 0 0
Dolj
Country [87] 0 0
Romania
State/province [87] 0 0
Galati
Country [88] 0 0
Romania
State/province [88] 0 0
Iasi
Country [89] 0 0
Romania
State/province [89] 0 0
Timisoara
Country [90] 0 0
Spain
State/province [90] 0 0
A Coruña
Country [91] 0 0
Spain
State/province [91] 0 0
Almeria
Country [92] 0 0
Spain
State/province [92] 0 0
Barcelona
Country [93] 0 0
Spain
State/province [93] 0 0
Sevilla
Country [94] 0 0
Spain
State/province [94] 0 0
Valencia
Country [95] 0 0
Sweden
State/province [95] 0 0
Göteborg
Country [96] 0 0
Sweden
State/province [96] 0 0
Karlstad
Country [97] 0 0
Sweden
State/province [97] 0 0
Lund
Country [98] 0 0
Sweden
State/province [98] 0 0
Uppsala
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Belfast
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Chesterfield
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Dundee
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Nottingham
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Sheffield
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Welwyn Garden City

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anna Maria Langkilde
Address 0 0
AstraZeneca
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 are available at https://clinicaltrials.gov/study/NCT02268214