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Clinical Trials/EUCTR2017-004709-42-NL
EUCTR2017-004709-42-NL
Active, not recruiting
Phase 1

An open-label randomised cross-over study to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes - DECADE

Martini Hospital0 sites17 target enrollmentMarch 28, 2018
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Martini Hospital
Enrollment
17
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 28, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Type 2 diabetes
  • •HbA1c \= 7\.5% (58 mmol/mol) and \<10% (86 mmol/mol)
  • •eGFR \> 30 ml/min/1\.73m2
  • •Albumin:creatinine ratio \>3\.5mg/mmol and \=100 mg/mmol
  • •Age \= 18 years
  • •RAS\-blockade either by ACEI or ARB, or willingness to start ACEI or ARB treatment
  • •Written informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •Pregnant women and women of child\-bearing potential who are not using reliable contraception
  • •Cardiovascular disease
  • •Uncontrolled blood pressure (office bp \> 160/ 100 mmHg)
  • •Active malignancy
  • •History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension)
  • •Use of SGLT\-2 inhibitor, GLP1\-RA or DPP\-4 inhibitor.
  • •Lithium use

Outcomes

Primary Outcomes

Not specified

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