drugset / Trial / NCT03660683

Effect of Saxagliptin and Dapagliflozin on Endothelial Progenitor Cell in Patients With Type 2 Diabetes Mellitus

NCT03660683

Phase 4 Terminated 15 enrolled Sabyasachi Sen
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The Investigator hypothesize that Dapagliflozin will improve EPC number and function AND Saxagliptin in addition to Dapagliflozin (additive effect) may improve EPC number and function even more than Dapa alone, compared to placebo. The Investigator propose a 3-arm randomized, parallel group, longitudinal study of 16-week intervention duration. Participants will be randomized to 3 groups: Group A: Dapa (10 mg) + Saxa Placebo, Enroll n=15, retain n=12 Group B: Dapa (10 mg) + Saxa (5 mg), Enroll n=15, retain n=12 Group C: Dapa Placebo + Saxa Placebo, Enroll n=15, retain n=12

Timeline

Start
2018-10-22
Primary completion
2021-03-11
Completion
2021-12-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 10 mg Oral
Comparator SAXAGLIPTIN ANHYDROUS Small molecule 5 mg Oral