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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
815

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 18, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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