CompletedPhase NAResults posted

An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes

Lead sponsor

University at Buffalo

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 1 diabetes

Eligibility highlights

•BMI 20-30•HbA1c 7-10%

Primary endpoint

•Beta-hydroxybutyrate Levels in Blood

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02962492

Org study ID1973

Timeline

Milestones

Study start2016-11-01actual

Study first posted2016-11-11estimated

Primary completion2021-02-01actual

Study completion2021-10-24actual

Last update posted2024-02-29actual

Results first posted2024-02-29actual

Assets

Investigational agents

Exenatide

Who this study enrolls

Type 1 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 1 Diabetes for at least 1 year on continuous subcutaneous insulin infusion (CSII; also known as insulin pump)

•HbA1c of 7-10% (inclusive)

•Ages 18-65 years (inclusive of ages 18 and 65)

•BMI 20-30 kg/m2

Exclusion criteria

•Inability to give informed consent

•Inability or refusal to comply with protocol

•Use of GLP-1 Receptor Agonists in the last 3 months or DPP-IV and SGLT-2 inhibitors therapy in the last 1 month.

•Risk for pancreatitis (e.g., history of gallstones, alcohol abuse, and hypertriglyceridemia)

•History of pancreatitis and or chronic pancreatitis

•Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) or stroke in the previous 3 months.

•Congestive Heart Failure class III or IV or tachyarrhythmia.

•Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver function defined as:

1. Aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN

2. Total bilirubin >2.0 mg/dL (34.2 µmol/L)

3. Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody

4. Liver function tests more than 3 times the upper limit of normal

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

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

•HIV positive

•History of gastroparesis

•History of medullary thyroid carcinoma or MEN 2 syndrome

•History of recurring UTI

•Uncontrolled thyroid disease (documented normal TSH), Cushing's syndrome, congenital adrenal hyperplasia or hyperprolactinemia.

•Prior history of a malignant disease requiring chemotherapy or patients with a prior history of bladder cancer regardless of treatment

•Alcoholism or drug addiction.

•Hypertriglyceridemia (>400 mg/dl).

•Any other life-threatening, non-cardiac disease

•Uncontrolled hypertension (BP > 160/95 mm of Hg)

•Patients with hypotension or at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics or recently donated >500ml of blood should have careful monitoring of their volume status

•Pregnant or breastfeeding patients or patient not willing to use two barrier method contraception during study period (unless sterilized or have an IUD)

•Use of hormonal medications, 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

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

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

•Known hypersensitivity to heparin/ IV catheter equipment.

•Eating disorders (anorexia, bulimia) or gastrointestinal disorders

•Having a history of bariatric surgery

•Debilitating psychiatric disorder such as psychosis or neurological condition that might confound outcome variables

•Use of an investigational agent or therapeutic regimen within 30 days of study

•Participation in any other concurrent clinical trial

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.

Coverage by outcome category

Cardiometabolic biomarkers

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in HbA1c Following Treatment

Time frame:12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Mean · Percent of Hemoglobin (%)	95% CI
Dapagliflozin Arm:	-0.3	-
Exenatide Extended Release Arm:	-0.4	-
Placebo Arm:	-0.1	-
Exenatide Extended Release & Dapagliflozin Arm:	-0.9	-

Secondary/protocol endpoint

Change in Total Insulin Dose

Time frame:12 weeks

change from baseline, improvement

Posted result

Group	Mean · Units/Kg	95% CI
Placebo Arm:	-0.01	-
Dapagliflozin Arm:	-0.02	-
Exenatide Extended Release Arm:	-0.05	-
Exenatide Extended Release & Dapagliflozin Arm:	-0.04	-

Cardiometabolic biomarkers

3 endpoints

Primary/protocol endpoint

Change in Beta-hydroxybutyrate Levels in Blood

Time frame:12 weeks

change from baseline, improvement

Posted result

Group	Mean · mM	95% CI
Placebo Arm:	-0.23	-
Dapagliflozin Arm:	0.63	-
Exenatide Extended Release Arm:	0.24	-
Exenatide Extended Release & Dapagliflozin Arm:	0.31	-

Secondary/protocol endpoint

Change in Urinary Beta-hydroxybutyrate (BHB) After 12 Weeks of Treatment

Time frame:12 weeks

urinary BHB

change from baseline, descriptive

Posted result

Group	Mean · mM	95% CI
Placebo Arm:	1.2	-
Dapagliflozin Arm:	0.4	-
Exenatide Extended Release Arm:	-0.7	-
Exenatide Extended Release & Dapagliflozin Arm:	1.1	-

Secondary/protocol endpoint

Change in Plasma Glucagon

Time frame:12 weeks

plasma glucagon

change from baseline, descriptive

Posted result

Group	Mean · pg/ml	95% CI
Placebo Arm:	2	-
Dapagliflozin Arm:	16	-
Exenatide Extended Release Arm:	-15	-
Exenatide Extended Release & Dapagliflozin Arm:	-10	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.