Effect of Chronic Exenatide Therapy on Beta Cell Function and Insulin Sensitivity in T2DM

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT02981069
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    10mg
  • Exenatide — DRUG
    Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)
  • Placebo — DRUG
    Placebo for Dapagliflozin

Study Details

In this study, the researchers hope to learn about SGLT2 inhibition on EGP (endogenous glucose production) and plasma glucose concentration in diabetic subjects. Researchers will examine diabetes and the role of increased plasma glucagon, decline in plasma insulin, and fall in plasma glucose concentration.

Key Dates

Start date
Dec 15, 2017
Status verified
Jun 2023
Primary completion
Jul 14, 2022
Completion
Mar 19, 2023

Study Design

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

Arms

  • Active Comparator: Byetta / Bydureon
    Exenatide: 4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc
  • Active Comparator: Dapagliflozin
    4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg
  • Active Comparator: Byetta/Bydureon plus Dapagliflozin
    Exenatide: 4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc PLUS Dapagliflozin: 4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg
  • Placebo Comparator: Placebo
    Placebo group (4 weeks and 12 weeks)

Primary Outcome Measure

Change in Endogenous Glucose Production (EGP) After Acute Exposure to a Single Dose and Again After 16 Weeks of Treatment [ Time Frame: ACUTE [after a single dose of each study drug or placebo] ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Health Science CenterSan AntonioTexas78229-

Find similar trials in San Antonio, TX

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Texas Health Science Center· San Antonio, TX

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