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Trial record 5 of 1485 for:    Type 1 Diabetes Mellitus 5

The Safety and Efficacy of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM

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ClinicalTrials.gov Identifier: NCT02582814
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Dapagliflozin 5 mg Drug: Dapagliflozin 10mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 26, 2015
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : June 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: dapagliflozin 5mg + insulin
dapagliflozin tablet 5mg + adjustable insulin
Drug: Dapagliflozin 5 mg
Dapagliflozin, a blood glucose lowering drug. Oral dose

Experimental: dapagliflozin 10mg + insulin
dapagliflozin tablet 10mg + adjustable insulin
Drug: Dapagliflozin 10mg
Dapagliflozin, a blood glucose lowering drug. Oral dose




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582814


Locations
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Japan
Research Site
Aizu Wakamatsu-shi, Japan
Research Site
Chuo-ku, Japan
Research Site
Fukuoka-shi, Japan
Research Site
Fukuyama-shi, Japan
Research Site
Funabashi-shi, Japan
Research Site
Hamamatsu-shi, Japan
Research Site
Hirosaki-shi, Japan
Research Site
Ise-shi, Japan
Research Site
Kagoshima-shi, Japan
Research Site
Koriyama-shi, Japan
Research Site
Kumamoto-shi, Japan
Research Site
Kunitachi-shi, Japan
Research Site
Minato-ku, Japan
Research Site
Nagoya-shi, Japan
Research Site
Oita-shi, Japan
Research Site
Otsu-shi, Japan
Research Site
Oyama-shi, Japan
Research Site
Sapporo-shi, Japan
Research Site
Sendai-shi, Japan
Research Site
Shinjyuku-ku, Japan
Research Site
Suita-shi, Japan
Research Site
Tama-shi, Japan
Research Site
Tsukuba-shi, Japan
Research Site
Yokohama-shi, Japan
Sponsors and Collaborators
AstraZeneca
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Statistical Analysis Plan  [PDF] March 16, 2017
Study Protocol  [PDF] December 14, 2016


Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02582814     History of Changes
Other Study ID Numbers: D1695C00001
First Posted: October 21, 2015    Key Record Dates
Results First Posted: April 12, 2019
Last Update Posted: April 12, 2019
Last Verified: January 2019
Keywords provided by AstraZeneca:
Japanese patients with type 1 diabetes with inadequate glycemic control on insulin
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action