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GLP-1 Receptor Agonist

Dapagliflozin for Type 2 Diabetes

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

Study Summary

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

Eligible Conditions
  • Type 2 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change in Fasting Plasma Glucose (FPG) Concentration
Change in Plasma Glucagon Concentration
Change in Plasma Insulin Concentration

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
4,262 Previous Clinical Trials
288,595,152 Total Patients Enrolled
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,324 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the key goals of this clinical investigation?

"This 16-week clinical trial aims to observe the effect of Dapagliflozin plus exenatide (Bydureon) on Endogenous Glucose Production. Secondary objectives include comparing Change in EGP for Exenatide (Byetta), Dapagliflozin, and Dapagliflozin/Exenatide versus Placebo."

Answered by AI

Does my profile meet the requirements to participate in this experiment?

"This medical investigation is seeking 88 individuals aged 18 to 70 with diabetes mellitus, type 2. Additionally, it's essential that applicants possess the following criteria: BMI 25-35 kg/m^2; minimal fluctuation in body weight over the prior three months; and overall good health based on physical examination, patient history, bloodwork analysis, CBC count, TSH level detection, thyroid hormone measure (T4), electrocardiogram readout and urinalysis results."

Answered by AI

What adverse effects may be associated with the combination of Byetta/Bydureon and Dapagliflozin?

"Our team of experts rated the safety of this combination therapy at a 3, given that it is already approved and available for clinical use."

Answered by AI

What conditions are usually addressed with a Byetta/Bydureon plus Dapagliflozin regimen?

"Byetta/Bydureon plus Dapagliflozin can be employed for pharmaceutical preparations, as well as supplemental interventions like diet and exercise when monotherapy is deemed insufficient."

Answered by AI

Does this medical research accept participants aged over 75?

"Adhering to the study criteria, individuals must be at least 18 years old and no older than 70 in order to take part."

Answered by AI

Is this research initiative currently accepting volunteers?

"As per the information on clinicaltrials. gov, this trial is not open to new participants as of now; however, it was first listed in December 2017 and last updated in September 2022. Despite being closed for recruitment at present, there are 1592 other trials recruiting patients presently."

Answered by AI

How many participants are included in the trial?

"This particular trial is not presently registering patients. Initially posted on December 15th 2017 and most recently updated on September 12th 2022, it has ceased accepting candidates. If you are still in search of research studies to join, there are currently 1,512 medical trials recruiting diabetics type 2 and 80 other investigations that study the effects of Byetta/Bydureon paired with Dapagliflozin."

Answered by AI

Is this an original research investigation?

"Presently, 80 clinical trials for Byetta/Bydureon plus Dapagliflozin are taking place across 239 cities and 50 nations. The first iteration of this drug trial was conducted in 2007 by CellTrans Inc., involving a cohort of 21 patients that successfully completed Phase 3 regulatory approval. Since then, 18618 studies have been concluded."

Answered by AI
~12 spots leftby Apr 2025