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CompletedPhase 4Results posted

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

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

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

90

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 25-35HbA1c 7-10%

Primary endpoints

Endogenous Glucose Production (EGP) After Acute Exposure to a Single DoseEndogenous Glucose Production (EGP) After 16 Weeks of Treatment With Each Study

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02981069
Org study IDHSC20160597H

Timeline

Milestones

Study first posted2016-12-02estimated
Study start2017-12-15actual
Primary completion2022-07-14actual
Study completion2023-03-19actual
Last update posted2023-07-20actual
Results first posted2023-07-20actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. BMI = 25-35 kg/m^2

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

3. HbA1c >7.0% and <10.0%

4. 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.

5. Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.

Exclusion criteria

1. 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

2. 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

3. 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.

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

5. Significantly elevated triglyceride levels (fasting triglyceride > 400 mg/dl), uncontrolled increased LDL-C

6. Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg)

7. Use of anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, , GnRH agonists, glucocorticoids, anabolic steroids, C-19 progestins) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors (finesteride, spironolactone, flutamide) stopped for at least 4 weeks

8. Prior history of a malignant disease requiring chemotherapy, prior history of bladder cancer regardless treatment

9. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status

10. History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 1, confirmed by a follow-up sample at next scheduled visit.

11. Presence of hypersensitivity to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions

12. Known hypersensitivity or contraindications to use GLP1 receptor agonists (exenatide, liraglutide)

13. Use of , thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 8 weeks.

14. Eating disorders (anorexia, bulimia) or gastrointestinal disorders

15. Suspected pregnancy (documented negative serum β-hCG test), desiring pregnancy in next 6 months, breastfeeding, or known pregnancy in last 2 months

16. Active history of illicit substance abuse or significant intake of alcohol

17. Having a history of bariatric surgery

18. Patient not willing to use two barrier method contraception during study period (unless sterilized or have an IUD)

19. Debilitating uncontrolled psychiatric disorder such as psychosis or neurological condition that might confound outcome variables

20. Inability or refusal to comply with protocol

21. Current participation or participation in an experimental drug study in previous three months

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint/low confidence

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]

change from baseline, improvement

Posted result

GroupValue (mean), mg/kg.min95% CI
EXENATIDE-0.18
Dapagliflozin0.14
Exenatide Plus Dapagliflozin-0.08
Placebo-0.03
Primary/protocol endpoint

Change in Endogenous Glucose Production (EGP) After 16 Weeks of Treatment With Each Study Drug.

Time frame:16 weeks

change from baseline, improvement

Posted result

GroupValue (mean), mg/kg.min95% CI
EXENATIDE-0.23
Dapagliflozin0.20
Exenatide Plus Dapagliflozin-0.12
Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG) Concentration

Time frame:16 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mg/dl95% CI
Byetta / Bydureon42
Dapagliflozin72
Byetta/Bydureon Plus Dapagliflozin11
Secondary/protocol endpoint

Change in Plasma Glucagon Concentration

Time frame:Baseline to 16 weeks

change from baseline, improvement

Posted result

GroupValue (mean), pg/ml95% CI
Dapa+Exe4
Dapa5
Exenatide-6
Secondary/protocol endpoint

Change in Plasma Insulin Concentration

Time frame:Baseline to 16 weeks

change from baseline, improvement

Posted result

GroupValue (mean), microUnits/ml95% CI
Dapa+Exe-2
Dapa-2
Exenatide3

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.