- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02582814
The Safety and Efficacy of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
A Clinical Pharmacology and Long Term Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With Type 1 Diabetes Who Have Inadequate Glycemic Control
This study will enroll eligible subjects into a long-term safety study (Part B).
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Aizu Wakamatsu-shi, Japan
- Research Site
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Chuo-ku, Japan
- Research Site
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Fukuoka-shi, Japan
- Research Site
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Fukuyama-shi, Japan
- Research Site
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Funabashi-shi, Japan
- Research Site
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Hamamatsu-shi, Japan
- Research Site
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Hirosaki-shi, Japan
- Research Site
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Ise-shi, Japan
- Research Site
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Kagoshima-shi, Japan
- Research Site
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Koriyama-shi, Japan
- Research Site
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Kumamoto-shi, Japan
- Research Site
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Kunitachi-shi, Japan
- Research Site
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Minato-ku, Japan
- Research Site
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Nagoya-shi, Japan
- Research Site
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Oita-shi, Japan
- Research Site
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Otsu-shi, Japan
- Research Site
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Oyama-shi, Japan
- Research Site
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Sapporo-shi, Japan
- Research Site
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Sendai-shi, Japan
- Research Site
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Shinjyuku-ku, Japan
- Research Site
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Suita-shi, Japan
- Research Site
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Tama-shi, Japan
- Research Site
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Tsukuba-shi, Japan
- Research Site
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Yokohama-shi, Japan
- Research Site
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed Written Informed Consent
- 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:
- Target Disease Exceptions History of T2DM Maturity onset diabetes of young (MODY) Any anti-hyperglycemic agent use, other than α-GI or insulin, within 1 month prior to the enrolment.
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: dapagliflozin 5mg + insulin
dapagliflozin tablet 5mg + adjustable insulin
|
Dapagliflozin, a blood glucose lowering drug.
Oral dose
|
Experimental: dapagliflozin 10mg + insulin
dapagliflozin tablet 10mg + adjustable insulin
|
Dapagliflozin, a blood glucose lowering drug.
Oral dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Adverse Event Summary
Time Frame: From baseline to 52 weeks
|
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
|
From baseline to 52 weeks
|
Hypoglycemia
Time Frame: From baseline to 52 weeks
|
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
|
From baseline to 52 weeks
|
Diabetic Ketoacidosis (DKA)
Time Frame: From baseline to 52 weeks
|
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
|
From baseline to 52 weeks
|
Vital Signs (Heart Rate)
Time Frame: From baseline to 52 weeks
|
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
|
From baseline to 52 weeks
|
ECGs
Time Frame: From baseline to 52 weeks
|
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
|
From baseline to 52 weeks
|
Clinical Laboratory Measures, Urine Test Results (Any Marked Abnormality)
Time Frame: From baseline to 52 weeks
|
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
|
From baseline to 52 weeks
|
Vital Signs (Blood Pressure)
Time Frame: From baseline to 52 weeks
|
To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.
|
From baseline to 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjusted Change From Baseline in HbA1c
Time Frame: From baseline to 24/52 weeks
|
To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy.
|
From baseline to 24/52 weeks
|
Adjusted Percent Change From Baseline in Total Daily Insulin Dose
Time Frame: From baseline to 24/52 weeks
|
To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy.
|
From baseline to 24/52 weeks
|
Adjusted Percent Change From Baseline in Body Weight
Time Frame: From baseline to 24/52 weeks
|
To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy.
|
From baseline to 24/52 weeks
|
Adjusted Change From Baseline in Glycoalbumin
Time Frame: From baseline to 24/52 weeks
|
To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy.
|
From baseline to 24/52 weeks
|
Adjusted Change From Baseline in Average Daily Glucose Measured by 6-point SMBG
Time Frame: From baseline to 24/52 weeks
|
To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy.
|
From baseline to 24/52 weeks
|
Adjusted Change From Baseline in Post-prandial Glucose Measured by 6-point SMBG
Time Frame: From baseline to 24/52 weeks
|
To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy.
|
From baseline to 24/52 weeks
|
Proportion of Subjects Achieving HbA1c Reduction of 0.5 Percent Without Severe Hypoglycemia
Time Frame: From baseline to 24/52 weeks
|
To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin
|
From baseline to 24/52 weeks
|
Proportion of Subjects Achieving HbA1c Reduction of 0.5 Percent
Time Frame: From baseline to 24/52 weeks
|
To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin
|
From baseline to 24/52 weeks
|
Proportion of Subjects Achieving HbA1c < 7.0 Percent
Time Frame: From baseline to 24/52 weeks
|
To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin
|
From baseline to 24/52 weeks
|
Adjusted Change From Baseline in SBP in Subjects With Baseline SBP/DBP >= 140/90 mmHg
Time Frame: From baseline to 24/52 weeks
|
To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin
|
From baseline to 24/52 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Sodium-Glucose Transporter 2 Inhibitors
- Dapagliflozin
Other Study ID Numbers
- D1695C00001
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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