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Clinical Trials/EUCTR2017-001779-22-DK
EUCTR2017-001779-22-DK
Active, Not Recruiting
Phase 1

The Effect of Empagliflozin on Cardiac and Kidney Metabolism in Persons with Type 2 Diabetes

Aarhus University Hospital, Department of Endocrinology0 sites13 target enrollmentMay 22, 2017
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ConditionsDiabetes, type 2MedDRA version: 20.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000072461Therapeutic area: Body processes [G] - Physiological processes [G07]
DrugsJardiance

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Diabetes, type 2
Sponsor
Aarhus University Hospital, Department of Endocrinology
Enrollment
13
Status
Active, Not Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 22, 2017
End Date
December 19, 2019
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Aarhus University Hospital, Department of Endocrinology

Eligibility Criteria

Inclusion Criteria

  • •Age: 50\-70 years
  • •Type 2 diabetes for \> 1 år
  • •HbA1c: 53\-75 mmol/mol
  • •Metformin treatment as only anti diabetic medicin
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 9
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 3

Exclusion Criteria

  • •Diabetes for less than 1 year
  • •Changes in any kind of medicine through the last one month before beginning of the study.
  • •Recent acute myocardial infarction (\< 1 year) , liver disease (ALAT \> x 3 of upper normal range), kidney failure (eGFR\<60 ml/min), current or previous cancer disease, anaemia (Hb \< 6,5\)
  • •Previous ketoacidosis
  • •Several genital infections (bacterial/fungal infections)
  • •Blooddonation the last 3 months before beginning of the study
  • •Participation in examinations with radioactive isotopes during the last 6 months before beginning of the study
  • •Current alcohol abuse (more than 21 units per week)

Outcomes

Primary Outcomes

Not specified

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