Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

NCT02460978 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 815

Last updated 2019-03-05

Study results available
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Summary

The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Dapagliflozin

Tablets

OTHER

Placebo for dapagliflozin

Tablets

Sponsors & Collaborators

Principal Investigators

  • Anna Maria Langkilde, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-08
Primary Completion
2017-09-02
Completion
2018-04-18

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • Chile
  • Germany
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

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 NCT02460978 on ClinicalTrials.gov