Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes (DEPICT 1)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02268214 |
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Recruitment Status :
Completed
First Posted : October 20, 2014
Results First Posted : March 29, 2018
Last Update Posted : September 13, 2018
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Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Type 1 Diabetes Mellitus |
| Interventions |
Drug: Dapagliflozin Drug: Placebo for dapagliflozin |
| Enrollment | 833 |
Participant Flow
| Recruitment Details | The first subject was enrolled on 11 November 2014. The last subject completed the 24-week short-term treatment period 04 January 2017 and the last subject completed the study 25 August 2017. This study was conducted at 138 sites in 17 countries. |
| Pre-assignment Details | 833 participants were randomized to a treatment group. Of the 771 participants not randomized to a treatment group: 585 No longer met study criteria, 125 withdrew consent, 26 were lost to follow-up, and 35 did not continue for other reasons |
| Arm/Group Title | Dapagliflozin 5 mg + Insulin | Dapagliflozin 10 mg + Insulin | Placebo + Insulin |
|---|---|---|---|
 Arm/Group Description |
Dapagliflozin 5 mg oral tablet once daily + background insulin | Dapagliflozin 10 mg oral tablet once daily + background insulin | Placebo oral tablet once daily + background insulin |
| Period Title: Overall Study | |||
| Started | 277 | 296 | 260 |
| COMPLETED 24 WEEK PERIOD | 252 | 273 | 232 |
| Completed | 235 | 255 | 218 |
| Not Completed | 42 | 41 | 42 |
| Reason Not Completed | |||
| Subject no longer meets study criteria | 0 | 2 | 0 |
| Pregnancy | 2 | 2 | 1 |
| Lost to Follow-up | 3 | 3 | 4 |
| Lack of Efficacy | 1 | 0 | 2 |
| Adverse Event | 11 | 14 | 9 |
| Withdrawal by Subject | 4 | 5 | 10 |
| Subject request to discontinue treatment | 10 | 8 | 6 |
| Poor/non-compliance | 2 | 1 | 2 |
| Other reasons | 7 | 3 | 3 |
| Not entering long-term period | 2 | 3 | 5 |
Baseline Characteristics
| Arm/Group Title | Dapagliflozin 5 mg + Insulin | Dapagliflozin 10 mg + Insulin | Placebo + Insulin | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Dapagliflozin 5 mg oral tablet once daily + background insulin | Dapagliflozin 10 mg oral tablet once daily + background insulin | Placebo oral tablet once daily + background insulin | Total of all reporting groups | |
| Overall Number of Baseline Participants | 277 | 296 | 260 | 833 | |
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Baseline Analysis Population Description |
Safety Analysis Set: It consists of all subjects who received at least one dose of double-blind study medication during the short-term double-blind treatment period.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 277 participants | 296 participants | 260 participants | 833 participants | |
| 42.1 (13.94) | 43.4 (13.89) | 42.7 (13.57) | 42.7 (13.80) | ||
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 277 participants | 296 participants | 260 participants | 833 participants | |
| < 65 years |
262 94.6%
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279 94.3%
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246 94.6%
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787 94.5%
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| Between 65 and 75 years |
15 5.4%
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16 5.4%
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14 5.4%
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45 5.4%
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| >= 75 years |
0 0.0%
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1 0.3%
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0 0.0%
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1 0.1%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 277 participants | 296 participants | 260 participants | 833 participants | |
| Female |
158 57.0%
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144 48.6%
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128 49.2%
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430 51.6%
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| Male |
119 43.0%
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152 51.4%
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132 50.8%
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403 48.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
If an Investigator requests permission to publish data from this study any such publication is to be agreed with AstraZeneca (AZ) in advance. The investigator agrees to provide AZ as soon as possible with drafts of proposed publications. Unless otherwise agreed, AZ shall have a period of 60 days from receipt of the proposed final manuscript to review it and may within such time require that submission for publication of the manuscript be delayed in order for AZ to file patent applications.
Results Point of Contact
| Name/Title: | Anna Maria Langkilde |
| Organization: | AstraZenenca |
| Phone: | +46 31 7761000 |
| EMail: | ClinicalTrialTransparency@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT02268214 |
| Other Study ID Numbers: |
MB102-229 2013-004674-97 ( EudraCT Number ) D1695C00006 ( Other Identifier: AstraZenenca ) |
| First Submitted: | October 15, 2014 |
| First Posted: | October 20, 2014 |
| Results First Submitted: | March 2, 2018 |
| Results First Posted: | March 29, 2018 |
| Last Update Posted: | September 13, 2018 |