Dexlar

WithdrawnPhase 4

Efficacy of Exenatide-LAR and Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Type 2 Diabetes

Efficacy of Exenatide-LAR Alone and in Combination With Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Uncontrolled Type 2 Diabetes

Lead sponsor

Weill Medical College of Cornell University

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

—

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c 8-12%

Primary endpoint

•HbA1c, change

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 IDNCT02811484

Org study ID1512016843

Timeline

Milestones

Study first posted2016-06-23estimated

Last update posted2017-03-03actual

Study start2016-06 (month precision)

Primary completion2018-06estimated (month precision)

Study completion2018-12estimated (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of Type 2 diabetes

•BMI ≥27kg/m^2

•Hemoglobin A1C 8-12%

•English speaking

•provided written consent

•on a stable dose of metformin and/or glitazone and/or alpha-glucosidase inhibitors for ≥ to 8 weeks

Exclusion criteria

•History of type 1 diabetes

•fasting c-peptide <.8 ng/ml

•eGFR <60 ml/min/1.73 m^2

•urine albumin-to-creatinine ratio greater or equal to 300 mg/g

•AST/ALT greater or equal to 2.5 upper limits of normal

•history of infectious liver disease (HBV, HCV)

•creatine kinase greater or equal to 3 times the upper limits of normal

•unstable or serious cardiovascular, renal, or hepatic disease

•symptoms of severely uncontrolled diabetes

•history of more than 1 episode of severe/major hypoglycemia within 6 months, active/history of bladder cancer

•female patients who are pregnant or intending to become pregnant

•women who are breastfeeding

•personal/family history of medullary thyroid cancer or MEN2

•fasting triglyceride levels > 500 mg/dl

•history of confirmed pancreatitis

•known hypersensitivity or allergy to exenatide or dapagliflozin

•are currently enrolled in or discontinued within last 30 days from another study

•have any other condition that precludes the patient from following and completing the protocol

•history of diabetic ketoacidosis

•anti-diabetes medication other than those listed in the inclusion criteria within 8 weeks of screening

•history of previous bariatric surgery or planned bariatric surgery during the course of the study

•clinically significant abnormal free T4/TSH requiring initiation or adjustment of thyroid treatment

Endpoints (7)

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

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in Body Weight

Time frame:baseline, 24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:baseline, 24 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Change in HbA1c

Time frame:baseline, 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting glucose

Time frame:baseline, 24 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in total dose insulin

Time frame:baseline, 24 weeks

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change in fasting lipids

Time frame:baseline, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in blood pressure

Time frame:baseline, 24 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.