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

NCT03970044 | Completed Phase 4 FDA Drug

• 1 other identifier: WCCR-2019-1
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase IV, single site, randomized, open-label, parallel study comparing BYDUREON-BCise plus FARXIGA to BYDUREON-BCise alone and FARXIGA alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• MAGE

  Compare the change in mean amplitude of glucose excursions from baseline to week 14

  14 weeks

Secondary Outcomes (7)

• Fasting Plasma Glucose

  14 weeks

• HbA1c

  14 weeks

• Weight

  14 weeks

• Blood Pressure

  14 weeks

• Blood Glucose Variability

  14 weeks

Study Arms (3)

Exenatide 2 mg plus Dapagaliflozin 10 mg

EXPERIMENTAL

Exenatide extended release, 2 mg weekly, injected Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment

Drug: Exenatide 2 MG; Drug: Dapagliflozin 10 MG

Exenatide 2 mg

ACTIVE COMPARATOR

Exenatide extended release, 2 mg weekly, injected 14 weeks of treatment

Drug: Exenatide 2 MG

Dapagaliflozin 10 mg

ACTIVE COMPARATOR

Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment

Drug: Dapagliflozin 10 MG

Interventions

Exenatide 2 MG DRUG

Glucagon-like peptide-1 receptor

Also known as: Bydureon, Bydureon BCise, Byetta

Exenatide 2 mg; Exenatide 2 mg plus Dapagaliflozin 10 mg

Dapagliflozin 10 MG DRUG

sodium-glucose co-transporter 2 (SGLT2) inhibitor

Also known as: Farxiga 10 MG

Dapagaliflozin 10 mg; Exenatide 2 mg plus Dapagaliflozin 10 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consano Clinical Research, LLC: lead

Study Sites (1)

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide; dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: July 2, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)