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Clinical Trials/NL-OMON46820
NL-OMON46820
Completed
Phase 3

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 Ziekenhuis0 sites20 target enrollmentTBD
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ConditionsdiabetesDiabetes Mellitus10012653

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
diabetes
Sponsor
Martini Ziekenhuis
Enrollment
20
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\* Type 2 diabetes
  • •\* HbA1c \* 6\.5% (48 mmol/mol)
  • •\* eGFR \> 30 ml/min/1\.73m2
  • •\* Albumin:creatinine ratio \>3\.5mg/mmol and \*100 mg/mmol
  • •\* Age \* 18 years
  • •\* Written informed consent

Exclusion Criteria

  • •\* Pregnant women and women of child\-bearing potential who are not using reliable contraception
  • •\* Cardiovascular disease: myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I\-IV) \< 6 months before inclusion
  • •\* Uncontrolled blood pressure (\> 160/ 100 mmHg)
  • •\* Active malignancy
  • •\* History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension)
  • •\* Participation in any clinical investigation within 3 months prior to initial dosing.
  • •\* Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing
  • •\* History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
  • •\* Use of SGLT\-2 inhibitor, GLP1\-RA or DPP\-4 inhibitor.
  • •\* Lithium use

Outcomes

Primary Outcomes

Not specified

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