Completed

Exenatide and Dapagliflozin Co-administration Impact on Glucose Production in Type 2 Diabetes

Study Aim

This study aims to evaluate the impact of Exenatide and Dapagliflozin, either separately or in combination, on glucose production in individuals with Type 2 Diabetes, after both a single dose and 16 weeks of treatment.

What is being tested

Dapagliflozin

+ Exenatide

+ Placebo

Drug

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 70 Years

+26 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 4

Interventional

Study Start: December 2017

See protocol details

Summary

Principal SponsorThe University of Texas Health Science Center at San Antonio

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 15, 2017

Actual date on which the first participant was enrolled.

This study focuses on Type 2 Diabetes Mellitus (T2DM) and explores the effects of combining two medications, exenatide and dapagliflozin. The goal is to understand if using these drugs together can prevent an increase in Endogenous Glucose Production (EGP) and lead to a greater decrease in blood sugar levels compared to using each drug individually. This research is important as it could potentially improve treatment options for those living with Type 2 Diabetes. Participants in this study will undergo a measurement of their EGP after an overnight fast. This involves a prime-continuous infusion of 3-3H-glucose. After this, they will receive either a placebo, exenatide (5 ug subcutaneously), dapagliflozin (10 mg), or both dapagliflozin and exenatide. The study will track changes in EGP after a single dose and again after 16 weeks of treatment. The results will be compared to understand the effectiveness of each treatment approach.

Official TitleEffect of Chronic Exenatide Therapy on Beta Cell Function and Insulin Sensitivity in Type 2 Diabetes Mellitus (T2DM)

NCT02981069

Principal SponsorThe University of Texas Health Science Center at San Antonio

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

5 inclusion criteria required to participate

BMI = 25-35 kg/m^2

must be drug naïve and/or on a stable dose (more than 3 months) of metformin and/or sulfonylurea

HbA1c >7.0% and <10.0%

Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis.

Show More Criteria

21 exclusion criteria prevent from participating

Presence of significant systemic disease, heart problems including congestive heart failure, unstable angina or acute myocardial infarction, current infectious liver disease, acute stroke or transient ischemic attacks, history of pancreatitis, urosepsis and pyelonephritis, genital mycotic infections, or Type 1 diabetes mellitus

Any hepatic diseases in the past (infectious liver disease, viral hepatitis, toxic hepatic damage, jaundice of unknown etiology) or severe hepatic insufficiency and/or significant abnormal liver function tests defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN

Renal impairment (e.g., serum creatinine levels ≥1.4 mg/dL for women or ≥1.5 mg/dl for men, or eGFR <60 mL/min/1.73 m2) or history of unstable or rapidly progressing renal disease or end stage renal disease.

Uncontrolled thyroid disease , Cushing's syndrome, congenital adrenal hyperplasia or hyperprolactinemia

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

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 II

Active Comparator

4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg

Group III

Active Comparator

Exenatide: 4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc

Group IV

Placebo

Placebo group (4 weeks and 12 weeks)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Texas Health Science Center

San Antonio, United StatesOpen University of Texas Health Science Center in Google Maps

CompletedOne Study Center