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Completed

NCT Number: NCT02460978

Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

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About this study

Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

Tablets

Placebo for dapagliflozin

Other

Tablets

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Acronym: DEPICT 2

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 3, 2015
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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