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

August 16, 2018 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Study Type

Interventional

Enrollment (Actual)

833

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Concord, Australia, 2139
        • Research Site
      • Daw Park, Australia, 5041
        • Research Site
      • Fitzroy, Australia, 3065
        • Research Site
      • Heidelberg West, Australia, 3081
        • Research Site
      • Newcastle, Australia, 2291
        • Research Site
      • Southport, Australia, 4215
        • Research Site
      • Wollongong, Australia, 2500
        • Research Site
  • Austria
      • Innsbruck, Austria, 6020
        • Research Site
      • Saint Stefan/Stainz, Austria, 8511
        • Research Site
      • Wien, Austria, 1130
        • Research Site
      • Wien, Austria, 1090
        • Research Site
      • Wien, Austria, 1060
        • Research Site
  • Belgium
      • Bonheiden, Belgium, 2820
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liege, Belgium, B-4000
        • Research Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Research Site
    • Quebec
      • Laval, Quebec, Canada, H7T 2P5
        • Research Site
  • Denmark
      • Arhus C, Denmark, 8000
        • Research Site
      • Esbjerg, Denmark, 6700
        • Research Site
      • Odense, Denmark, 5000
        • Research Site
      • Randers NØ, Denmark, 8930
        • Research Site
  • Finland
      • Helsinki, Finland, 00014
        • Research Site
      • Jyvaskyla, Finland, 40100
        • Research Site
      • Kuopio, Finland, 70100
        • Research Site
      • Oulu, Finland, 90100
        • Research Site
      • Tampere, Finland, 33520
        • Research Site
  • France
      • Besançon Cedex, France, 25000
        • Research Site
      • Corbeil-Essonnes, France, 91106
        • Research Site
      • Dijon, France, 21000
        • Research Site
      • SAINT HERBLAIN Cedex, France, 44805
        • Research Site
      • Vandoeuvre les Nancy, France, 54500
        • Research Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • Research Site
      • Aßlar, Germany, 35614
        • Research Site
      • Bad Oeynhausen, Germany, 32545
        • Research Site
      • Falkensee, Germany, 14612
        • Research Site
      • Munich, Germany, 80939
        • Research Site
      • Munster, Germany, 48145
        • Research Site
      • Neuwied, Germany, 56564
        • Research Site
      • Oldenburg, Germany, 23758
        • Research Site
      • Pohlheim, Germany, 35415
        • Research Site
      • Schweinfurt, Germany, 97421
        • Research Site
      • Sulzbach, Germany, 92237
        • Research Site
      • Witten, Germany, 58455
        • Research Site
  • Hungary
      • Baja, Hungary, 6500
        • Research Site
      • Balatonfured, Hungary, 8230
        • Research Site
      • Budapest, Hungary, 1213
        • Research Site
      • Létavértes, Hungary, 4281
        • Research Site
      • Szeged, Hungary, 6726
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Research Site
  • Israel
      • Haifa, Israel, 31096
        • Research Site
      • Jerusalem, Israel, 91120
        • Research Site
      • Safed, Israel, 13100
        • Research Site
      • Tel-Aviv, Israel, 61480
        • Research Site
      • Tikva, Israel, 49202
        • Research Site
  • Italy
      • Firenze, Italy, 50141
        • Research Site
      • Milano, Italy, 20132
        • Research Site
      • Padowa, Italy, 35100
        • Research Site
      • Palermo, Italy, 90127
        • Research Site
      • Ravenna, Italy, 48100
        • Research Site
      • Sesto San Giovanni, Italy, 20099
        • Research Site
      • Siena, Italy, 53100
        • Research Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Research Site
      • Chihuahua, Mexico, 31237
        • Research Site
      • Cuernavaca, Mexico, 62250
        • Research Site
      • Guadalajara, Mexico, 44150
        • Research Site
      • Merida, Mexico, 97070
        • Research Site
      • Mexico, Mexico, 6090
        • Research Site
      • Monterrey, Mexico, 64460
        • Research Site
      • Monterrey, Mexico, 64020
        • Research Site
      • Torreon, Mexico, 27000
        • Research Site
      • Zapopan, Mexico, 45116
        • Research Site
      • Zapopan, Jalisco, Mexico, 45200
        • Research Site
  • Romania
      • Bucuresti, Romania, 010825
        • Research Site
      • Bucuresti, Romania, 020045
        • Research Site
      • Dolj, Romania, 200134
        • Research Site
      • Galati, Romania, 800098
        • Research Site
      • Iasi, Romania, 700515
        • Research Site
      • Timisoara, Romania, 300736
        • Research Site
  • Spain
      • A Coruña, Spain, 15006
        • Research Site
      • Almeria, Spain, 04001
        • Research Site
      • Barcelona, Spain, 08036
        • Research Site
      • Sevilla, Spain, 41071
        • Research Site
      • Valencia, Spain, 46009
        • Research Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Research Site
      • Karlstad, Sweden, 651 85
        • Research Site
      • Lund, Sweden, 22185
        • Research Site
      • Uppsala, Sweden, 75185
        • Research Site
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Research Site
      • Chesterfield, United Kingdom, S40 4AA
        • Research Site
      • Dundee, United Kingdom, DD1 9SY
        • Research Site
      • Nottingham, United Kingdom, NG7 2UH
        • Research Site
      • Sheffield, United Kingdom, S5 7AU
        • Research Site
      • Welwyn Garden City, United Kingdom, AL7 4HQ
        • Research Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Encino, California, United States, 91436
        • Research Site
      • La Mesa, California, United States, 91942
        • Research Site
      • San Diego, California, United States, 92161
        • Research Site
      • Tarzana, California, United States, 91356
        • Research Site
      • Torrance, California, United States, 90502
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
      • Denver, Colorado, United States, 80220
        • Research Site
    • Florida
      • Cooper City, Florida, United States, 33024
        • Research Site
      • Jacksonville, Florida, United States, 32258
        • Research Site
      • Miami, Florida, United States, 33136
        • Research Site
      • Port Orange, Florida, United States, 32127
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404-7596
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Research Site
    • Maine
      • Portland, Maine, United States, 04101
        • Research Site
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Research Site
      • Rockville, Maryland, United States, 20852
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Research Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Research Site
    • New York
      • Albany, New York, United States, 12206
        • Research Site
      • Buffalo, New York, United States, 14215
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Research Site
      • Chapel Hill, North Carolina, United States, 27517
        • Research Site
      • Greenville, North Carolina, United States, 27834
        • Research Site
      • Morehead City, North Carolina, United States, 28557
        • Research Site
    • Pennsylvania
      • Langhorne, Pennsylvania, United States, 19047
        • Research Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Research Site
      • Nashville, Tennessee, United States, 37212
        • Research Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Research Site
      • Dallas, Texas, United States, 75230
        • Research Site
      • Houston, Texas, United States, 77090
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Research Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Dapagliflozin
Dapagliflozin 5 mg tablet orally, once daily for 52 weeks
Drug: Dapagliflozin
Tablets
Experimental: Arm B: Dapagliflozin
Dapagliflozin 10 mg tablet orally, once daily for 52 weeks
Drug: Dapagliflozin
Tablets
Placebo Comparator: Arm C: Placebo for Dapagliflozin
Placebo tablet orally, once daily for 52 weeks
Drug: Placebo for dapagliflozin
Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Change in HbA1c From Baseline at Week 24
Time Frame: From Baseline to Week 24
Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model[RMM]).
From Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24
Time Frame: From Baseline to Week 24
Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model[RMM])
From Baseline to Week 24
Adjusted Mean Percent Change in Body Weight From Baseline at Week 24
Time Frame: From Baseline to Week 24
Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model[RMM])
From Baseline to Week 24
Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24
Time Frame: From Baseline to Week 24
Adjusted mean change in 24-hour mean Continuous Glucose Monitoring glucose from baseline at Week 24 (Repeated Measures Model[RMM])
From Baseline to Week 24
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24
Time Frame: From Baseline to Week 24
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring Mean Amplitude of Glucose Excursions (MAGE) from Baseline at Week 24 (Repeated Measures Model[RMM])
From Baseline to Week 24
Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24
Time Frame: From Baseline to Week 24
Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) from Baseline at Week 24 (Repeated Measures Model[RMM])
From Baseline to Week 24
Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events
Time Frame: From Baseline to Week 24
Subjects with HbA1c reduction from baseline to week 24 (LOCF) >= 0.5% and without severe hypoglycemia events
From Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Anna Maria Langkilde, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2014

Primary Completion (Actual)

January 4, 2017

Study Completion (Actual)

August 25, 2017

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB102-229
  • 2013-004674-97 (EudraCT Number)
  • D1695C00006 (Other Identifier: AstraZenenca)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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