Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D)

• Status: Completed
• Trial end date: 2019-08-22
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of dapagliflozin, a FDA approved diabetes medication, on measures of nervous system function of the heart in patients with type 2 diabetes. The investigators will compare the effect of dapagliflozin with an active comparator, glimepiride (a different FDA approved diabetes medication) on measures of heart rate variability and assess whether dapagliflozin has modulating effects on measures of nervous system function of the heart. This is a crossover study design where all participants will receive both study medications equally (12-week intervention periods) in a certain order.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: AstraZeneca
• Treatments: Dapagliflozin; Glimepiride

Criteria

Inclusion Criteria:

1. Patients with type 2 diabetes as defined on background metformin monotherapy who are not meeting ADA standard of care recommended glucose target.

2. Age ≥18 years

Exclusion Criteria:

1. History of multiple urinary tract infections

2. Patients with mycotic infections especially genital infections.

3. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status. This is listed as exclusion criteria but then it says that they just need careful monitoring. Is it an exclusion or not?

4. Severely hypotensive patients

5. History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 1, confirmed by a follow-up sample at next scheduled visit.

6. Presence of hypersensitivity to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions

7. Inability or refusal to comply with protocol

8. Current participation or participation in an experimental drug study in the previous three months

9. History of diabetic ketoacidosis

10. Planned cardiac surgery or angioplasty within 3 months

11. Recent history of acute CV events such as MI, stroke, PAD within 3 months prior to enrollment

12. Patients with severe renal impairment or unstable or rapidly progressing renal disease or end stage renal disease.

13. Clinical conditions that could interfere with the cardiovascular autonomic function and heart rate variability (arrhythmias)

14. Severe hepatic insufficiency and/or significant abnormal liver function (defined as aspartate aminotransferase >3× upper limit of normal (ULN) and/or alanine aminotransferase >3× ULN) or creatinine kinase >3× ULN.

15. History of cancer other than basal cell carcinoma and/or treatment for cancer within the last 5 years

16. Women of child-bearing potential who may be pregnant or lactating.

17. History of pancreas, kidney or liver transplant

18. History of drug or alcohol abuse

19. History of allergy to sulfa drugs

20. Presence of any condition that, in the opinion of the investigator would make it unlikely for the subject to complete the study

21. Congestive heart failure (CHF) defined as New York Heart Association class III and IV