GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4

Effectiveness of Exenatide Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.

Effectiveness of Once-weekly Exenatide (BCise) Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.

Lead sponsor

Consano Clinical Research, LLC

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c 7.5-12%

Primary endpoint

•MAGE

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 IDNCT03970044

Org study IDWCCR-2019-1

Timeline

Milestones

Study first posted2019-05-31actual

Study start2019-07-02actual

Primary completion2021-06-01actual

Study completion2021-06-01actual

Last update posted2021-08-30actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Willing and able to give informed written consent prior to any tudy specific procedures

•Male or female, age 18 to 75 years

•Diagnosis of T2DM

•HbA1c >7.5% and <12% obtained at Screening

•Treated with a stable dose of metformin alone (>1500 mg/day) or max tolerated dose for at least 8 weeks prior to Screening

•Body mass index (BMI) <45 kg/m2

•Women of childbearing potential (WOCBP), defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), must agree to use 2 medically accepted, effective methods of birth control (e.g., hormonal contraceptive, barrier contraceptive with additional spermicide, tubal ligation, or an intrauterine device) prior to IP administration and continuing throughout the study and continuing for 10 weeks after the intake of the last dose of IP

•Females who are postmenopausal must have been postmenopausal for >1 year if they wish not to use contraceptives. If postmenopausal status is questionable, the patient's follicle-stimulating hormone level must be checked and must be elevated and consistent with postmenopausal levels (i.e., >40 IU/L); otherwise these patients must agree to use contraceptives listed above

•Males who are sexually active with WOCBP must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign consent) and for 10 weeks following the last intake of IP to prevent pregnancy in a partner

Exclusion criteria

•Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)

•Previous enrolment in the present study

•Participation in a study within 30 days of planned enrolment in this study and at least 5 half-lives of the investigational product (IP) the patient received in a previous study

•Positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of IP

•Women who are pregnant, breastfeeding, or plan to become pregnant during the course of the study

•History of taking OAD medications other than metformin, during the 8 weeks prior to screening, or have been on insulin therapy within 1 year of screening (with the exception of insulin therapy for rescue or use in gestational diabetes)

•Treated with a GLP-1 receptor agonist within 6 months

•Have a condition that is a contraindicated for use of exenatide (Bydureon BCise), dapagliflozin (Farxiga) or metformin per FDA approved prescribing information

•History of diabetic ketoacidosis requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 3 month prior to screening

•An estimated glomerular filtration rate (eGFR <60 mL/min/1.73 m2 at Screening. A one-time repeat measurement is permitted at the discretion of the investigator, if the value is not consistent with prior values

•History of acute pancreatitis associated or not with using an anti-diabetic drug therapy

•Active liver disease and/or significant abnormal liver function defined as AST > 2 x ULN and/or ALT > 2x ULN and /or serum total bilirubin > 2.0 mg/dl

•History of frequent urinary and/or genital mycotic infections as determined by the investigator

•Uncontrolled thyroid disease as determined by the investigator

•Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma

•Significant cardiovascular history, as determined per Investigator's discretion

•Ingestion of prescription or over-the-counter weight loss medications during the 3 months prior to screening

•Have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (eg, Lap-Band®) or chronically take drugs that directly reduce gastrointestinal motility

•Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable doses of replacement corticosteroid therapy may be enrolled)

•A history of prior amputation, peripheral vascular disease, or diabetic foot ulcers

•History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed

•Any condition or clinically significant abnormality, which in the Investigator's opinion, may render the patient unable to complete the study or which may pose significant risk to the patient or successful completion of the study.

Endpoints (8)

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

1 endpoint

Secondary/protocol endpoint

Weight

Time frame:14 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

MAGE

Time frame:14 weeks

change from baseline, improvement

Secondary/protocol endpoint

Fasting Plasma Glucose

Time frame:14 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

HbA1c

Time frame:14 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Blood Glucose Variability

Time frame:14 weeks

change from baseline, improvement

Secondary/protocol endpoint

24 Hour Mean Blood Glucose

Time frame:17 weeks

change from baseline, improvement

Secondary/protocol endpoint

Blood Glucose Time In Range

Time frame:14 weeks

CGM time-in-range

percent change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Blood Pressure

Time frame:14 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.