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Trial record 5 of 17 for:    Dapagliflozin type 1 diabetes insulin

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02460978
First received: June 1, 2015
Last updated: June 12, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Type 1 Diabetes Mellitus Drug: Dapagliflozin Other: Placebo for dapagliflozin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in Hemoglobin A1C (HbA1c) at Week 24 [ Time Frame: From the first dose of study medication to Week 24 ]
    Baseline will correspond to the last available assessment prior to the first dose of double-blind study medication.


Secondary Outcome Measures:
  • Percent change in total daily insulin dose [ Time Frame: From the first dose of study medication to Week 24 ]
    Baseline will correspond to the last available assessment prior to the first dose of double-blind study medication.

  • Percent change in body weight [ Time Frame: From the first dose of study medication to Week 24 ]
    Baseline will correspond to the last available assessment prior to the first dose of double-blind study medication.

  • Change in the mean value of 24-hour glucose readings obtained from continuous Glucose Monitoring (CGM) [ Time Frame: From the first dose of study medication to Week 24 ]
    Baseline will correspond to the last availble average prior to the first dose of double-blind study medication.

  • Change in mean amplitude of glucose excursion of 24-hour glucose readings obtained from CGM [ Time Frame: From the first dose of study medication to Week 24 ]
    Baseline will correspond to the last availble average prior to the first dose of double-blind study medication.

  • Change in the percent of 24-hour glucose readings obtained from CGM that falls within the range of > 70 mg/dL and ≤ 180 mg/dL [ Time Frame: From the first dose of study medication to Week 24 ]
    Baseline will correspond to the last availble average prior to the first dose of double-blind study medication.

  • Proportion of subjects achieving an HbA1c reduction ≥ 0.5% and without severe hypoglycemia events [ Time Frame: From the first dose of study medication to Week 24 ]
    Baseline will correspond to the last available assessment prior to the first dose of double-blind study medication.


Other Outcome Measures:
  • Proportion of subjects with hypoglycemia events and the frequency and severity of the hypoglycemia events [ Time Frame: From the first dose of study medication over the 24-week double-blind treatment period. ]
  • Safety and tolerability by assessment of adverse events (AEs), vital signs, diabetic ketoacidosis events, physical examination findings, laboratory values [ Time Frame: From the first dose of study medication over the 24-week double-blind treatment period. ]
    Baseline will correspond to the last available assessment prior to the first dose of double-blind study medication.


Enrollment: 727
Actual Study Start Date: July 8, 2015
Estimated Study Completion Date: April 20, 2018
Estimated Primary Completion Date: September 18, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02460978

  Show 136 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Anna Maria Langkilde, MD AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02460978     History of Changes
Other Study ID Numbers: MB102-230
2014-004599-49 ( EudraCT Number )
D1695C00007 ( Other Identifier: AstraZeneca )
Study First Received: June 1, 2015
Last Updated: June 12, 2017

Keywords provided by AstraZeneca:
Dapagliflozin
Efficacy
Safety
Add on to insulin
Oral Antidiabetic
Type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 21, 2017