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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Sabyasachi Sen
Study ID
NCT03660683
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg — DRUG
    Dapagliflozin 10mg PO QD
  • Saxagliptin 5mg — DRUG
    Saxagliptin 5 mg PO QD
  • Placebo Oral Tablet — DRUG
    Matching Placebo Tablets

Study Details

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

Key Dates

Start date
Oct 22, 2018
Status verified
Jun 2023
Primary completion
Mar 11, 2021
Completion
Dec 10, 2021

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A Dapa
    Dapagliflozin 10 mg + Saxagliptin Placebo
  • Active Comparator: Group B DapaSaxa
    Dapagliflozin 10mg + Saxagliptin 5mg
  • Placebo Comparator: Placebo
    Placebo Oral Tablet

Primary Outcome Measure

CD 34+ Cell Migratory Function [ Time Frame: 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
The GW Medical Faculty AssociatesWashington D.C.District of Columbia20037-

Find similar trials in Washington D.C., DC

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
The GW Medical Faculty Associates· Washington D.C., DC

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