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GLP-1 Receptor Agonist

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

Phase 4
Waitlist Available
Led By Eugenio Cersosimo, MD,PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will study the effects of SGLT2 inhibitors on blood sugar levels in people with diabetes.

Eligible Conditions
  • Type 2 Diabetes
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~acute [after a single dose of each study drug or placebo]
This trial's timeline: 3 weeks for screening, Varies for treatment, and acute [after a single dose of each study drug or placebo] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Endogenous Glucose Production (EGP) After 16 Weeks of Treatment With Each Study Drug.
Change in Endogenous Glucose Production (EGP) After Acute Exposure to a Single Dose and Again After 16 Weeks of Treatment
Secondary study objectives
Change in Fasting Plasma Glucose (FPG) Concentration
Change in Plasma Glucagon Concentration
Change in Plasma Insulin Concentration

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: DapagliflozinActive Control1 Intervention
4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg
Group II: Byetta / BydureonActive Control1 Intervention
Exenatide: 4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc
Group III: Byetta/Bydureon plus DapagliflozinActive Control2 Interventions
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
Group IV: PlaceboPlacebo Group1 Intervention
Placebo group (4 weeks and 12 weeks)

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,427 Previous Clinical Trials
289,164,362 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
477 Previous Clinical Trials
92,880 Total Patients Enrolled
Eugenio Cersosimo, MD,PhDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
2 Previous Clinical Trials
62 Total Patients Enrolled
~11 spots leftby Dec 2025
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