Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes

NCT02268214 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 833

Last updated 2018-09-13

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

DRUG

Placebo for dapagliflozin

Tablets

Sponsors & Collaborators

Principal Investigators

  • Anna Maria Langkilde · 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
2014-11-11
Primary Completion
2017-01-04
Completion
2017-08-25

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Romania
  • Spain
  • Sweden
  • 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 NCT02268214 on ClinicalTrials.gov