Back to resultsDapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes (DEPICT 2)
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 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
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Dapagliflozin 5 mg
Dapagliflozin 10 mg
Placebo
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 From Baseline in HbA1c at Week 24
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
Secondary Outcome Measures
Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24
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
Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24
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
Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24
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
Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24
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
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
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
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
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
Full Information
NCT ID
NCT02460978
First Posted
June 1, 2015
Last Updated
February 14, 2019
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT02460978
Brief Title
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
Acronym
DEPICT 2
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 Two
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 8, 2015 (Actual)
Primary Completion Date
September 2, 2017 (Actual)
Study Completion Date
April 18, 2018 (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
815 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin 5 mg
Arm Type
Experimental
Arm Description
Dapagliflozin 5 mg tablet orally, once daily for 52 weeks
Arm Title
Dapagliflozin 10 mg
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg tablet orally, once daily for 52 weeks
Arm Title
Placebo
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
Other
Intervention Name(s)
Placebo for dapagliflozin
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in HbA1c at Week 24
Description
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
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24
Description
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
Time Frame
Baseline and 24 weeks
Title
Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24
Description
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
Time Frame
Baseline and 24 weeks
Title
Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24
Description
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
Time Frame
Baseline and 24 weeks
Title
Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24
Description
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
Time Frame
Baseline and 24 weeks
Title
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
Description
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
Time Frame
Baseline and 24 weeks
Title
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
Description
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
Time Frame
Baseline and 24 weeks
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Maria Langkilde, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
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Research Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
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Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
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Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
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United States
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Research Site
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
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United States
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Research Site
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
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United States
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Research Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
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United States
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Research Site
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
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United States
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Research Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
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Research Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
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Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
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Research Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
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Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
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Research Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
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Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
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United States
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Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Research Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
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Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
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
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
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Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
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Research Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Research Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Research Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
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Research Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Research Site
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
Research Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
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Research Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4824
Country
United States
Facility Name
Research Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Research Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
74194
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Research Site
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
Research Site
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
1180AAX
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1405BCH
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
1056
Country
Argentina
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
X5006IKK
Country
Argentina
Facility Name
Research Site
City
Corrientes
ZIP/Postal Code
3400
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Research Site
City
Ramos Mejía
ZIP/Postal Code
B1704ETD
Country
Argentina
Facility Name
Research Site
City
Brussels (Uccle)
ZIP/Postal Code
1180
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 4J2
Country
Canada
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Research Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 7L6
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
Facility Name
Research Site
City
Smiths Falls
State/Province
Ontario
ZIP/Postal Code
K7A 4W8
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
7500010
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8053095
Country
Chile
Facility Name
Research Site
City
Temuco
ZIP/Postal Code
4781156
Country
Chile
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Research Site
City
Falkensee
ZIP/Postal Code
14612
Country
Germany
Facility Name
Research Site
City
Freiburg im Breisgau
ZIP/Postal Code
79106
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69115
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
Saarlouis
ZIP/Postal Code
66740
Country
Germany
Facility Name
Research Site
City
Sulzbach-Rosenberg
ZIP/Postal Code
92237
Country
Germany
Facility Name
Research Site
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Research Site
City
Aki-gun
ZIP/Postal Code
735-0021
Country
Japan
Facility Name
Research Site
City
Amagasaki-shi
ZIP/Postal Code
661-0002
Country
Japan
Facility Name
Research Site
City
Chitose-shi
ZIP/Postal Code
066-0032
Country
Japan
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
103-0002
Country
Japan
Facility Name
Research Site
City
Fukuyama-shi
ZIP/Postal Code
721-0927
Country
Japan
Facility Name
Research Site
City
Higashiosaka-shi
ZIP/Postal Code
577-0802
Country
Japan
Facility Name
Research Site
City
Ibusuki-shi
ZIP/Postal Code
891-0401
Country
Japan
Facility Name
Research Site
City
Kagoshima-shi
ZIP/Postal Code
892-0824
Country
Japan
Facility Name
Research Site
City
Kamakura-shi
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Research Site
City
Kashiwara-shi
ZIP/Postal Code
582-0005
Country
Japan
Facility Name
Research Site
City
Kitakyushu-shi
ZIP/Postal Code
807-0857
Country
Japan
Facility Name
Research Site
City
Koriyama-shi
ZIP/Postal Code
963-8851
Country
Japan
Facility Name
Research Site
City
Kumamoto-shi
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Research Site
City
Kurume-shi
ZIP/Postal Code
830-8543
Country
Japan
Facility Name
Research Site
City
Miura-shi
ZIP/Postal Code
238-0101
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Research Site
City
Obihiro-shi
ZIP/Postal Code
080-0016
Country
Japan
Facility Name
Research Site
City
Oita-shi
ZIP/Postal Code
870-0855
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Research Site
City
Oyama-shi
ZIP/Postal Code
323-0022
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Research Site
City
Shibuya-ku
ZIP/Postal Code
150-0013
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Research Site
City
Shizuoka-shi
ZIP/Postal Code
424-0855
Country
Japan
Facility Name
Research Site
City
Tsukuba-shi
ZIP/Postal Code
305-0812
Country
Japan
Facility Name
Research Site
City
Ushiku-shi
ZIP/Postal Code
300-1207
Country
Japan
Facility Name
Research Site
City
Uwajima-shi
ZIP/Postal Code
798-8510
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
231-8682
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
235-0045
Country
Japan
Facility Name
Research Site
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
Facility Name
Research Site
City
Maastricht
ZIP/Postal Code
6020 AZ
Country
Netherlands
Facility Name
Research Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-156
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-261
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
Facility Name
Research Site
City
Warsaw
ZIP/Postal Code
04736
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Research Site
City
St.Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Research Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Research Site
City
Helsingborg
ZIP/Postal Code
25220
Country
Sweden
Facility Name
Research Site
City
Linkoping
ZIP/Postal Code
587 58
Country
Sweden
Facility Name
Research Site
City
Uddevalla
ZIP/Postal Code
451 80
Country
Sweden
Facility Name
Research Site
City
Olten
ZIP/Postal Code
4600
Country
Switzerland
Facility Name
Research Site
City
St. Gallen
ZIP/Postal Code
9016
Country
Switzerland
Facility Name
Research Site
City
Zollikerberg
ZIP/Postal Code
8125
Country
Switzerland
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Research Site
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Research Site
City
Oldham
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Facility Name
Research Site
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Research Site
City
Wakefield
ZIP/Postal Code
WF1 4DG
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
30026335
Citation
Mathieu C, Dandona P, Gillard P, Senior P, Hasslacher C, Araki E, Lind M, Bain SC, Jabbour S, Arya N, Hansen L, Thoren F, Langkilde AM; DEPICT-2 Investigators. Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes (the DEPICT-2 Study): 24-Week Results From a Randomized Controlled Trial. Diabetes Care. 2018 Sep;41(9):1938-1946. doi: 10.2337/dc18-0623. Epub 2018 Jul 19.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4122&filename=MB102230_CSP.pdf
Description
MB102230_CSP
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4122&filename=MB102230_SAP.pdf
Description
MB102230_SAP
Learn more about this trial
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
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