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A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients

NCT03387683 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2020-04-27

Study results available
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Summary

This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

dapagliflozin

dapagliflozin 10mg

DRUG

placebo

placebo to match dapagliflozin

Sponsors & Collaborators

Principal Investigators

  • Jonas Oldgren, MD, PhD · Uppsala Clinical Research Center, Upppsala Sweden

  • Pirjo Nuutila, MD, PhD · University of Turku, Turku, Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2019-03-19
Completion
2019-03-19

Countries

  • Finland
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
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 NCT03387683 on ClinicalTrials.gov