MedTrace Logo

The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM

NCT02582840 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-01-18

Study results available
· View outcomes & findings →

Summary

This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate glycemic control on insulin defined as HbA1c ≥ 7.0% and ≤ 10.0% at screening visit. lacebo-controlled design. Patients will be randomized in a 1:1:1 ratio into one of the 3 single-blinded treatment arms; dapagliflozin 5 mg, dapagliflozin 10 mg or placebo. CSII user are excluded.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Dapagliflozin 5mg

Dapagliflozin, a blood glucose lowering drug. Oral dose

DRUG

Dapagliflozin 10mg

Dapagliflozin, a blood glucose lowering drug. Oral dose

DRUG

Placebo tablet

Placebo tablet. Oral dose

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-06-30
Completion
2016-06-30

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 NCT02582840 on ClinicalTrials.gov