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SGLT2 Inhibitor

Dapagliflozin Arm: for Ketogenic Stress Test

N/A
Waitlist Available
Research Sponsored by University at Buffalo
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 12 weeks
Awards & highlights

Study Summary

The study investigations include evaluation of the acute effects of a single dose of dapagliflozin (10mg), exenatide (5µg), a combination of exenatide and dapagliflozin or placebo under insulinopenic condition and the long term effect under basal conditions before and after 12 weeks treatment with dapagliflozin, Exenatide extended release, a combination of Exenatide extended release and dapagliflozin or placebo on ketogenesis, glucagon and lipolysis.

Eligible Conditions
  • Ketogenic Stress Test

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Beta-hydroxybutyrate Levels in Blood
Secondary outcome measures
Change in HbA1c Following Treatment
Change in Plasma Glucagon
Change in Total Insulin Dose
+1 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Dapagliflozin Arm:Active Control1 Intervention
dapagliflozin 10mg (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)
Group II: Exenatide extended release Arm:Active Control1 Intervention
subcutaneous injection of Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin placebo
Group III: Exenatide extended release & dapagliflozin Arm:Active Control2 Interventions
Exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin 10mg
Group IV: Placebo Arm:Placebo Group1 Intervention
dapagliflozin placebo (oral tablet) and exenatide (5µg acutely)/Exenatide extended release (long term) placebo (subcutaneous injection)

Find a Location

Who is running the clinical trial?

University at BuffaloLead Sponsor
132 Previous Clinical Trials
98,909 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,612,789 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes
Paresh Dandona 2016. "An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02962492.
~8 spots leftby Apr 2025
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