Back to resultsDapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes (DEPICT 1)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dapagliflozin
Placebo for dapagliflozin
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Dapagliflozin, Efficacy, Safety, Add on to insulin, Oral Antidiabetic, Type 1 diabetes
Eligibility 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 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
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Arm A: Dapagliflozin
Arm B: Dapagliflozin
Arm C: Placebo for Dapagliflozin
Arm Description
Dapagliflozin 5 mg tablet orally, once daily for 52 weeks
Dapagliflozin 10 mg tablet orally, once daily for 52 weeks
Placebo tablet orally, once daily for 52 weeks
Outcomes
Primary Outcome Measures
Adjusted Mean Change in HbA1c From Baseline at Week 24
Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model[RMM]).
Secondary Outcome Measures
Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24
Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model[RMM])
Adjusted Mean Percent Change in Body Weight From Baseline at Week 24
Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model[RMM])
Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24
Adjusted mean change in 24-hour mean Continuous Glucose Monitoring glucose from baseline at Week 24 (Repeated Measures Model[RMM])
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at 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])
Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at 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])
Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events
Subjects with HbA1c reduction from baseline to week 24 (LOCF) >= 0.5% and without severe hypoglycemia events
Full Information
NCT ID
NCT02268214
First Posted
October 15, 2014
Last Updated
August 16, 2018
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT02268214
Brief Title
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Acronym
DEPICT 1
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 Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 11, 2014 (Actual)
Primary Completion Date
January 4, 2017 (Actual)
Study Completion Date
August 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Dapagliflozin, Efficacy, Safety, Add on to insulin, Oral Antidiabetic, Type 1 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
833 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Dapagliflozin
Arm Type
Experimental
Arm Description
Dapagliflozin 5 mg tablet orally, once daily for 52 weeks
Arm Title
Arm B: Dapagliflozin
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg tablet orally, once daily for 52 weeks
Arm Title
Arm C: Placebo for Dapagliflozin
Arm Type
Placebo Comparator
Arm Description
Placebo tablet orally, once daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo for dapagliflozin
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
Adjusted Mean Change in HbA1c From Baseline at Week 24
Description
Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model[RMM]).
Time Frame
From Baseline to Week 24
Secondary Outcome Measure Information:
Title
Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24
Description
Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model[RMM])
Time Frame
From Baseline to Week 24
Title
Adjusted Mean Percent Change in Body Weight From Baseline at Week 24
Description
Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model[RMM])
Time Frame
From Baseline to Week 24
Title
Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24
Description
Adjusted mean change in 24-hour mean Continuous Glucose Monitoring glucose from baseline at Week 24 (Repeated Measures Model[RMM])
Time Frame
From Baseline to Week 24
Title
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24
Description
Adjusted Mean Change in 24-hour Continuous Glucose Monitoring Mean Amplitude of Glucose Excursions (MAGE) from Baseline at Week 24 (Repeated Measures Model[RMM])
Time Frame
From Baseline to Week 24
Title
Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24
Description
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])
Time Frame
From Baseline to Week 24
Title
Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events
Description
Subjects with HbA1c reduction from baseline to week 24 (LOCF) >= 0.5% and without severe hypoglycemia events
Time Frame
From Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Maria Langkilde
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
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Research Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
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United States
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Research Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
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United States
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Research Site
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San Diego
State/Province
California
ZIP/Postal Code
92161
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United States
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Research Site
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
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United States
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Research Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
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United States
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Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
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United States
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Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
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United States
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City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
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United States
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Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32258
Country
United States
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Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
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United States
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Research Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
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United States
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Research Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-7596
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United States
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Research Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
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United States
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Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
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United States
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Research Site
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
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United States
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Research Site
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Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
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United States
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Research Site
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Rockville
State/Province
Maryland
ZIP/Postal Code
20852
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United States
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Research Site
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Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
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United States
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Research Site
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Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
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United States
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Research Site
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Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
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United States
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Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
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Research Site
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Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
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Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
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Research Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
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Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
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Research Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
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Research Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
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Research Site
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
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United States
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City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
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Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
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Research Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
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Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
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Research Site
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Research Site
City
Concord
ZIP/Postal Code
2139
Country
Australia
Facility Name
Research Site
City
Daw Park
ZIP/Postal Code
5041
Country
Australia
Facility Name
Research Site
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Research Site
City
Heidelberg West
ZIP/Postal Code
3081
Country
Australia
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Research Site
City
Newcastle
ZIP/Postal Code
2291
Country
Australia
Facility Name
Research Site
City
Southport
ZIP/Postal Code
4215
Country
Australia
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Research Site
City
Wollongong
ZIP/Postal Code
2500
Country
Australia
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Research Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Research Site
City
Saint Stefan/Stainz
ZIP/Postal Code
8511
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1060
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Research Site
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Y 3W2
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Research Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
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Research Site
City
Arhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Research Site
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Research Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Research Site
City
Randers NØ
ZIP/Postal Code
8930
Country
Denmark
Facility Name
Research Site
City
Helsinki
ZIP/Postal Code
00014
Country
Finland
Facility Name
Research Site
City
Jyvaskyla
ZIP/Postal Code
40100
Country
Finland
Facility Name
Research Site
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Research Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Research Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Research Site
City
Besançon Cedex
ZIP/Postal Code
25000
Country
France
Facility Name
Research Site
City
Corbeil-Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
Research Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Research Site
City
SAINT HERBLAIN Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Research Site
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Research Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Research Site
City
Aßlar
ZIP/Postal Code
35614
Country
Germany
Facility Name
Research Site
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Research Site
City
Falkensee
ZIP/Postal Code
14612
Country
Germany
Facility Name
Research Site
City
Munich
ZIP/Postal Code
80939
Country
Germany
Facility Name
Research Site
City
Munster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Research Site
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Facility Name
Research Site
City
Oldenburg
ZIP/Postal Code
23758
Country
Germany
Facility Name
Research Site
City
Pohlheim
ZIP/Postal Code
35415
Country
Germany
Facility Name
Research Site
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany
Facility Name
Research Site
City
Sulzbach
ZIP/Postal Code
92237
Country
Germany
Facility Name
Research Site
City
Witten
ZIP/Postal Code
58455
Country
Germany
Facility Name
Research Site
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Research Site
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1213
Country
Hungary
Facility Name
Research Site
City
Létavértes
ZIP/Postal Code
4281
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6726
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Research Site
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Research Site
City
Tel-Aviv
ZIP/Postal Code
61480
Country
Israel
Facility Name
Research Site
City
Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50141
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Research Site
City
Padowa
ZIP/Postal Code
35100
Country
Italy
Facility Name
Research Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Research Site
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Research Site
City
Sesto San Giovanni
ZIP/Postal Code
20099
Country
Italy
Facility Name
Research Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Research Site
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31237
Country
Mexico
Facility Name
Research Site
City
Cuernavaca
ZIP/Postal Code
62250
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44150
Country
Mexico
Facility Name
Research Site
City
Merida
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
6090
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Research Site
City
Torreon
ZIP/Postal Code
27000
Country
Mexico
Facility Name
Research Site
City
Zapopan, Jalisco
ZIP/Postal Code
45200
Country
Mexico
Facility Name
Research Site
City
Zapopan
ZIP/Postal Code
45116
Country
Mexico
Facility Name
Research Site
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Research Site
City
Bucuresti
ZIP/Postal Code
020045
Country
Romania
Facility Name
Research Site
City
Dolj
ZIP/Postal Code
200134
Country
Romania
Facility Name
Research Site
City
Galati
ZIP/Postal Code
800098
Country
Romania
Facility Name
Research Site
City
Iasi
ZIP/Postal Code
700515
Country
Romania
Facility Name
Research Site
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Research Site
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Research Site
City
Almeria
ZIP/Postal Code
04001
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Research Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Research Site
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Research Site
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Research Site
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Research Site
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Research Site
City
Chesterfield
ZIP/Postal Code
S40 4AA
Country
United Kingdom
Facility Name
Research Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Research Site
City
Welwyn Garden City
ZIP/Postal Code
AL7 4HQ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35403243
Citation
Melin J, Tang W, Rekic D, Hamren B, Penland RC, Boulton DW, Parkinson J. Dapagliflozin Pharmacokinetics Is Similar in Adults With Type 1 and Type 2 Diabetes Mellitus. J Clin Pharmacol. 2022 Oct;62(10):1227-1235. doi: 10.1002/jcph.2062. Epub 2022 May 2.
Results Reference
derived
PubMed Identifier
32946821
Citation
Groop PH, Dandona P, Phillip M, Gillard P, Edelman S, Jendle J, Xu J, Scheerer MF, Thoren F, Iqbal N, Repetto E, Mathieu C. Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials. Lancet Diabetes Endocrinol. 2020 Oct;8(10):845-854. doi: 10.1016/S2213-8587(20)30280-1.
Results Reference
derived
PubMed Identifier
32691513
Citation
Mathieu C, Dandona P, Birkenfeld AL, Hansen TK, Iqbal N, Xu J, Repetto E, Scheerer MF, Thoren F, Phillip M. Benefit/risk profile of dapagliflozin 5 mg in the DEPICT-1 and -2 trials in individuals with type 1 diabetes and body mass index >/=27 kg/m2. Diabetes Obes Metab. 2020 Nov;22(11):2151-2160. doi: 10.1111/dom.14144. Epub 2020 Aug 20.
Results Reference
derived
PubMed Identifier
30756462
Citation
Parkinson J, Tang W, Astrand M, Melin J, Ekholm E, Hamren B, Boulton DW. Model-based characterization of the relationship between dapagliflozin systemic exposure and HbA1c response in patients with type 1 diabetes mellitus. Diabetes Obes Metab. 2019 Jun;21(6):1381-1387. doi: 10.1111/dom.13664. Epub 2019 Mar 14.
Results Reference
derived
PubMed Identifier
30352894
Citation
Dandona P, Mathieu C, Phillip M, Hansen L, Tschope D, Thoren F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study. Diabetes Care. 2018 Dec;41(12):2552-2559. doi: 10.2337/dc18-1087. Epub 2018 Oct 23.
Results Reference
derived
PubMed Identifier
28919061
Citation
Dandona P, Mathieu C, Phillip M, Hansen L, Griffen SC, Tschope D, Thoren F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):864-876. doi: 10.1016/S2213-8587(17)30308-X. Epub 2017 Sep 14. Erratum In: Lancet Diabetes Endocrinol. 2017 Dec;5(12 ):e8.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3676&filename=MB102229-revprot2_1_15.08.17_Redacted.pdf
Description
MB102229_CSP
Learn more about this trial
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
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