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Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes (DEPICT 2)

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02460978
Recruitment Status : Completed
First Posted : June 3, 2015
Results First Posted : November 6, 2018
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Dapagliflozin Other: Placebo for dapagliflozin Phase 3

Detailed Description:
Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 815 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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 - Study Two
Actual Study Start Date : July 8, 2015
Actual Primary Completion Date : September 2, 2017
Actual Study Completion Date : April 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dapagliflozin 5 mg
Dapagliflozin 5 mg tablet orally, once daily for 52 weeks
 Drug: Dapagliflozin
Tablets
Experimental: Dapagliflozin 10 mg
Dapagliflozin 10 mg tablet orally, once daily for 52 weeks
 Drug: Dapagliflozin
Tablets
Placebo Comparator: Placebo
Placebo tablet orally, once daily for 52 weeks
 Other: Placebo for dapagliflozin
Tablets


Outcome Measures
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Primary Outcome Measures :
  1. Adjusted Mean Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline and 24 weeks ]
    To compare the change from baseline in HbA1c between dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment


Secondary Outcome Measures :
  1. Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24 [ Time Frame: Baseline and 24 weeks ]
    To compare the percent change from baseline in total daily insulin dose with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment

  2. Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24 [ Time Frame: Baseline and 24 weeks ]
    To compare the percentage change from baseline in body weight with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment

  3. Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24 [ Time Frame: Baseline and 24 weeks ]
    To compare the change from baseline in mean value of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment

  4. Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24 [ Time Frame: Baseline and 24 weeks ]
    To compare the change from baseline in mean amplitude of glucose excursions (MAGE) of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment

  5. Change From Baseline in the Percent of 24-hour Glucose Readings Obtained From CGM That Falls Within the Target Range of > 70 mg/dL and <= 180 mg/dL (%) at Week 24 [ Time Frame: Baseline and 24 weeks ]
    To compare the change from baseline in the percent of 24-hour glucose readings obtained from CGM that falls within the target range of >70 mg/dL and <=180 mg/dL with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment

  6. Percentage of Subjects With HbA1c Reduction From Baseline to Week 24 Last Observation Carried Forward (LOCF) >= 0.5% and Without Severe Hypoglycemia Events at Week 24 [ Time Frame: Baseline and 24 weeks ]
    To compare dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin for the proportion of subjects achieving an HbA1c reduction from baseline to Week 24 visit >=0.5% without severe hypoglycemia events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 any non-insulin antihyperglicemic agent 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
  • Taking metformin and/or thiazolidinediones within 2 months prior to screening
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460978


Locations
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Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
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Study Director: Anna Maria Langkilde, MD AstraZeneca
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Statistical Analysis Plan  [PDF] September 22, 2017
Study Protocol  [PDF] May 18, 2016

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02460978    
Other Study ID Numbers: MB102-230
2014-004599-49 ( EudraCT Number )
D1695C00007 ( Other Identifier: AstraZeneca )
First Posted: June 3, 2015    Key Record Dates
Results First Posted: November 6, 2018
Last Update Posted: March 5, 2019
Last Verified: February 2019
Keywords provided by AstraZeneca:
Dapagliflozin
Efficacy
Safety
 Add on to insulin
Oral Antidiabetic
Type 1 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs