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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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)
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Research Site - Concord
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Research Site - Daw Park
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Research Site - Fitzroy
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Research Site - Heidelberg West
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Research Site - Newcastle
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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
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Sheffield
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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
The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and
effective therapy to improve glycemic control in patients with type 1 diabetes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02268214
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02268214