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

NCT02582814 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2019-04-12

Study results available
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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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Dapagliflozin 5 mg

Dapagliflozin, a blood glucose lowering drug. Oral dose

DRUG

Dapagliflozin 10mg

Dapagliflozin, a blood glucose lowering drug. Oral dose

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-26
Primary Completion
2017-06-15
Completion
2017-06-15

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582814 on ClinicalTrials.gov