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

February 14, 2019 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 - Study Two

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)

815

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

  • Argentina
      • Buenos Aires, Argentina, C1405BCH
        • Research Site
      • Buenos Aires, Argentina, 1180AAX
        • Research Site
      • Caba, Argentina, 1056
        • Research Site
      • Cordoba, Argentina, 5000
        • Research Site
      • Cordoba, Argentina, X5006IKK
        • Research Site
      • Corrientes, Argentina, 3400
        • Research Site
      • Mar del Plata, Argentina, B7600FZN
        • Research Site
      • Ramos Mejía, Argentina, B1704ETD
        • Research Site
  • Belgium
      • Brussels (Uccle), Belgium, 1180
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 4J2
        • Research Site
      • Edmonton, Alberta, Canada, T6G 2E1
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Research Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7L6
        • Research Site
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Research Site
      • Ottawa, Ontario, Canada, K1H 7W9
        • Research Site
      • Smiths Falls, Ontario, Canada, K7A 4W8
        • Research Site
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Research Site
  • Chile
      • Santiago, Chile, 7500010
        • Research Site
      • Santiago, Chile, 8053095
        • Research Site
      • Temuco, Chile, 4781156
        • Research Site
  • Germany
      • Dresden, Germany, 1307
        • Research Site
      • Essen, Germany, 45355
        • Research Site
      • Falkensee, Germany, 14612
        • Research Site
      • Freiburg im Breisgau, Germany, 79106
        • Research Site
      • Hamburg, Germany, 22607
        • Research Site
      • Heidelberg, Germany, 69115
        • Research Site
      • Oldenburg, Germany, 23758
        • Research Site
      • Pohlheim, Germany, 35415
        • Research Site
      • Saarlouis, Germany, 66740
        • Research Site
      • Sulzbach-Rosenberg, Germany, 92237
        • Research Site
      • Wangen, Germany, 88239
        • Research Site
  • Japan
      • Aki-gun, Japan, 735-0021
        • Research Site
      • Amagasaki-shi, Japan, 661-0002
        • Research Site
      • Chitose-shi, Japan, 066-0032
        • Research Site
      • Chuo-ku, Japan, 103-0002
        • Research Site
      • Fukuyama-shi, Japan, 721-0927
        • Research Site
      • Higashiosaka-shi, Japan, 577-0802
        • Research Site
      • Ibusuki-shi, Japan, 891-0401
        • Research Site
      • Kagoshima-shi, Japan, 892-0824
        • Research Site
      • Kamakura-shi, Japan, 247-0056
        • Research Site
      • Kashiwara-shi, Japan, 582-0005
        • Research Site
      • Kitakyushu-shi, Japan, 807-0857
        • Research Site
      • Koriyama-shi, Japan, 963-8851
        • Research Site
      • Kumamoto-shi, Japan, 862-0976
        • Research Site
      • Kurume-shi, Japan, 830-8543
        • Research Site
      • Miura-shi, Japan, 238-0101
        • Research Site
      • Nagoya-shi, Japan, 455-8530
        • Research Site
      • Obihiro-shi, Japan, 080-0016
        • Research Site
      • Oita-shi, Japan, 870-0855
        • Research Site
      • Osaka-shi, Japan, 530-0001
        • Research Site
      • Oyama-shi, Japan, 323-0022
        • Research Site
      • Sapporo-shi, Japan, 060-0001
        • Research Site
      • Shibuya-ku, Japan, 150-0013
        • Research Site
      • Shinjuku-ku, Japan, 169-0073
        • Research Site
      • Shizuoka-shi, Japan, 424-0855
        • Research Site
      • Tsukuba-shi, Japan, 305-0812
        • Research Site
      • Ushiku-shi, Japan, 300-1207
        • Research Site
      • Uwajima-shi, Japan, 798-8510
        • Research Site
      • Yokohama-shi, Japan, 231-8682
        • Research Site
      • Yokohama-shi, Japan, 235-0045
        • Research Site
  • Netherlands
      • Hoogeveen, Netherlands, 7909 AA
        • Research Site
      • Maastricht, Netherlands, 6020 AZ
        • Research Site
      • Utrecht, Netherlands, 3584 CX
        • Research Site
  • Poland
      • Białystok, Poland, 15-435
        • Research Site
      • Białystok, Poland, 15-351
        • Research Site
      • Gdańsk, Poland, 80-546
        • Research Site
      • Krakow, Poland, 31-501
        • Research Site
      • Kraków, Poland, 31-156
        • Research Site
      • Kraków, Poland, 31-261
        • Research Site
      • Lublin, Poland, 20-044
        • Research Site
      • Warsaw, Poland, 04736
        • Research Site
      • Wroclaw, Poland, 51-685
        • Research Site
  • Russian Federation
      • Novosibirsk, Russian Federation, 630091
        • Research Site
      • Saint Petersburg, Russian Federation, 199034
        • Research Site
      • Saint-Petersburg, Russian Federation, 194354
        • Research Site
      • St. Petersburg, Russian Federation, 191015
        • Research Site
      • St.Petersburg, Russian Federation, 194354
        • Research Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Research Site
      • Helsingborg, Sweden, 25220
        • Research Site
      • Linkoping, Sweden, 587 58
        • Research Site
      • Uddevalla, Sweden, 451 80
        • Research Site
  • Switzerland
      • Olten, Switzerland, 4600
        • Research Site
      • St. Gallen, Switzerland, 9016
        • Research Site
      • Zollikerberg, Switzerland, 8125
        • Research Site
  • United Kingdom
      • Manchester, United Kingdom, M23 9LT
        • Research Site
      • Northampton, United Kingdom, NN1 5BD
        • Research Site
      • Oldham, United Kingdom, OL1 2JH
        • Research Site
      • Swansea, United Kingdom, SA2 8QA
        • Research Site
      • Wakefield, United Kingdom, WF1 4DG
        • Research Site
  • United States
    • California
      • Concord, California, United States, 94520
        • Research Site
      • Fresno, California, United States, 93720
        • Research Site
      • Los Angeles, California, United States, 90057
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
      • San Mateo, California, United States, 94401
        • Research Site
      • San Ramon, California, United States, 94583
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
    • Colorado
      • Golden, Colorado, United States, 80401
        • Research Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Research Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • Research Site
      • Clearwater, Florida, United States, 33756
        • Research Site
      • Fort Lauderdale, Florida, United States, 33312
        • Research Site
      • Jacksonville, Florida, United States, 32216
        • Research Site
      • Miami, Florida, United States, 33156
        • Research Site
      • Miami Springs, Florida, United States, 33166
        • Research Site
      • Saint Petersburg, Florida, United States, 33709
        • Research Site
      • Tampa, Florida, United States, 33634
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Research Site
      • Atlanta, Georgia, United States, 30308
        • Research Site
      • Roswell, Georgia, United States, 30076
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Research Site
      • Chicago, Illinois, United States, 60607
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Research Site
      • Lexington, Kentucky, United States, 40502
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
        • Research Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Research Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Research Site
      • Saint Louis, Missouri, United States, 63110
        • Research Site
    • Nevada
      • Reno, Nevada, United States, 89511
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Research Site
    • New York
      • Albany, New York, United States, 12208
        • Research Site
      • Flushing, New York, United States, 11355
        • Research Site
      • Mineola, New York, United States, 11501
        • Research Site
      • New Hyde Park, New York, United States, 11042
        • Research Site
      • New York, New York, United States, 10029
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-4824
        • Research Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Research Site
      • Austin, Texas, United States, 78731
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Edinburg, Texas, United States, 78539
        • Research Site
      • Mesquite, Texas, United States, 74194
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
      • San Antonio, Texas, United States, 78258
        • Research Site
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Research Site
    • Washington
      • Federal Way, Washington, United States, 98003
        • 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 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

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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 24 weeks
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
Baseline and 24 weeks
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
Baseline and 24 weeks
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
Baseline and 24 weeks
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
Baseline and 24 weeks
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
Baseline and 24 weeks

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, MD, 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)

July 8, 2015

Primary Completion (Actual)

September 2, 2017

Study Completion (Actual)

April 18, 2018

Study Registration Dates

First Submitted

June 1, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (Estimate)

June 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB102-230
  • 2014-004599-49 (EudraCT Number)
  • D1695C00007 (Other Identifier: AstraZeneca)

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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