The Safety and Efficacy of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
NCT ID: NCT02582814
Last Updated: 2019-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
151 participants
INTERVENTIONAL
2015-10-26
2017-06-15
Brief Summary
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Japanese male and female patients with T1DM and age 18 to 75 years, with inadequate glycemic control on insulin defined as HbA1c ≥ 7.5% and ≤ 10.5% at screening visit. As a condition of enrollment, subjects must be on a total daily insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to the screening visit. The study design of Part B is a randomized, open-label, 2 arm, parallel-group design. 140 Japanese subjects in total will be randomized in a 1:1 ratio into one of the two treatment arms; dapagliflozin 5 mg or dapagliflozin 10 mg.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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dapagliflozin 5mg + insulin
dapagliflozin tablet 5mg + adjustable insulin
Dapagliflozin 5 mg
Dapagliflozin, a blood glucose lowering drug. Oral dose
dapagliflozin 10mg + insulin
dapagliflozin tablet 10mg + adjustable insulin
Dapagliflozin 10mg
Dapagliflozin, a blood glucose lowering drug. Oral dose
Interventions
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Dapagliflozin 5 mg
Dapagliflozin, a blood glucose lowering drug. Oral dose
Dapagliflozin 10mg
Dapagliflozin, a blood glucose lowering drug. Oral dose
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of T1DM. In addition, the following criteria also needs to be met; Central laboratory test of C-peptide \< 0.7 ng/mL
* Insulin use for at least 12 months prior to the enrolment per subject report or medical records and Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to the enrolment per subject report or medical records. Subjects must be taking a total daily insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to the enrolment. If on MDI insulin administration subject must be on ≥ 3x injections per day.
* Japanese men and women
* Screening Visit: Central laboratory HbA1c ≥ 7.5% and ≤ 10.5%
* BMI ≥ 20.0 kg/m² at visit 1
* Age 18 to 75 years, inclusive
Exclusion Criteria
Use of thiazolidinediones within 6 months prior to the enrolment History of DKA requiring medical intervention within 1 month prior to the enrolment History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to the enrolment
* Medical History and Concurrent Diseases Malignancy within 5 years of the enrolment (with the exception of treated basal cell or treated squamous cell carcinoma) History of bladder cancer History of radiation therapy to the lower abdomen or pelvis at any time
* Physical and Laboratory Test Findings Aspartate aminotransferase (AST) \> 3x upper limit of normal (ULN) Alanine aminotransferase (ALT) \> 3x ULN Serum total bilirubin (TB) \> 2.0 mg/dL (34.2 μmol/L) Estimated GFR (eGFR) by the Japanese Society of Nephrology formula ≤ 45 mL/min/1.73m2 Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women.
Positive for hepatitis B surface antigen or anti-hepatitis C virus antibody Abnormal Free T4
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Aizu Wakamatsu-shi, , Japan
Research Site
Chūōku, , Japan
Research Site
Fukuoka, , Japan
Research Site
Fukuyama-shi, , Japan
Research Site
Funabashi-shi, , Japan
Research Site
Hamamatsu, , Japan
Research Site
Hirosaki-shi, , Japan
Research Site
Ise-shi, , Japan
Research Site
Kagoshima, , Japan
Research Site
Koriyama-shi, , Japan
Research Site
Kumamoto, , Japan
Research Site
Kunitachi-shi, , Japan
Research Site
Minatoku, , Japan
Research Site
Nagoya, , Japan
Research Site
Oyama-shi, , Japan
Research Site
Ōita, , Japan
Research Site
Ōtsu, , Japan
Research Site
Sapporo, , Japan
Research Site
Sendai, , Japan
Research Site
Shinjyuku-ku, , Japan
Research Site
Suita-shi, , Japan
Research Site
Tama-shi, , Japan
Research Site
Tsukuba, , Japan
Research Site
Yokohama, , Japan
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Other Identifiers
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D1695C00001
Identifier Type: -
Identifier Source: org_study_id
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