Effectiveness of Exenatide Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.

Part of paid clinical trials in Shavano Park, Texas.

Sponsor
Consano Clinical Research, LLC
Study ID
NCT03970044
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Exenatide 2 MG — DRUG
    Glucagon-like peptide-1 receptor
  • Dapagliflozin 10 MG — DRUG
    sodium-glucose co-transporter 2 (SGLT2) inhibitor

Study Details

This is a Phase IV, single site, randomized, open-label, parallel study comparing BYDUREON-BCise plus FARXIGA to BYDUREON-BCise alone and FARXIGA alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.

Key Dates

Start date
Jul 2, 2019
Status verified
Aug 2021
Primary completion
Jun 1, 2021
Completion
Jun 1, 2021

Study Design

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

Arms

  • Experimental: Exenatide 2 mg plus Dapagaliflozin 10 mg
    Exenatide extended release, 2 mg weekly, injected Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment
  • Active Comparator: Exenatide 2 mg
    Exenatide extended release, 2 mg weekly, injected 14 weeks of treatment
  • Active Comparator: Dapagaliflozin 10 mg
    Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment

Primary Outcome Measure

MAGE [ Time Frame: 14 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Consano Clinical Research, LLCShavano ParkTexas78231-

Find similar trials in Shavano Park, TX

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Consano Clinical Research, LLC· Shavano Park, TX

Related Studies