CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 45 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02973477
NCT02973477Phase 4Completed

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

University of Michigan·interventional·Posted Nov 25, 2016·Updated Oct 22, 2020

In Brief

A Phase 4 clinical trial evaluating Dapagliflozin and Glimepiride for Type2 Diabetes and Cardiovascular Diseases. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 25, 2016
Enrollment StartJan 12, 2017
Primary CompletionAug 22, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.6 years ago

Interventions

Dapagliflozindrug

Dapagliflozin is a sodium glucose transporter-2 (SGLT-2) inhibitor, a new class of glucose lowering agent that reduces hyperglycemia in patients with T2D by reducing renal glucose reabsorption.

Glimepiridedrug

Glimepiride is a sulfonylurea agent that reduces hyperglycemia in patients with T2D by stimulating insulin release from the pancreatic beta cells and reduction of glucose output from the liver.