- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03970044
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a Phase IV, single site, randomized, open-label, 3 treatment group, parallel study comparing BYDUREON-BCiseTM plus FARXIGATM to BYDUREON-BCiseTM alone and FARXIGATM alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.
Patients who meet all inclusion and none of the exclusion criteria will enter a 1-week Lead-in Period, during which patients will be given a blood glucose meter and fitted with a blinded Continuous Glucose Monitor (CGM) and undergo a 14-day CGM assessment.
After the 1-week Lead-in Period, approximately 60 subjects will be randomized at a 1:1:1 ratio to one of three open-label treatment arms to achieve approximately 20 subjects per treatment arm.
The study consists of a 2-week Screening Period, a 1-week Lead-in Period, a 14-week open-label Treatment Period and a 10-week Follow-up Period.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Texas
-
Shavano Park, Texas, United States, 78231
- Consano Clinical Research, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Exenatide 2 mg plus Dapagaliflozin 10 mg
Exenatide extended release, 2 mg weekly, injected Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment
|
Glucagon-like peptide-1 receptor
Other Names:
sodium-glucose co-transporter 2 (SGLT2) inhibitor
Other Names:
|
ACTIVE_COMPARATOR: Exenatide 2 mg
Exenatide extended release, 2 mg weekly, injected 14 weeks of treatment
|
Glucagon-like peptide-1 receptor
Other Names:
|
ACTIVE_COMPARATOR: Dapagaliflozin 10 mg
Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment
|
sodium-glucose co-transporter 2 (SGLT2) inhibitor
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MAGE
Time Frame: 14 weeks
|
Compare the change in mean amplitude of glucose excursions from baseline to week 14
|
14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting Plasma Glucose
Time Frame: 14 weeks
|
Change in fasting plasma glucose from baseline to week 14
|
14 weeks
|
HbA1c
Time Frame: 14 weeks
|
Change in HbA1c from baseline to week 14
|
14 weeks
|
Weight
Time Frame: 14 weeks
|
Change in weight from baseline to week 14
|
14 weeks
|
Blood Pressure
Time Frame: 14 weeks
|
Change in blood pressure from baseline to week 14
|
14 weeks
|
Blood Glucose Variability
Time Frame: 14 weeks
|
Variability in blood glucose from baseline to weeks 4, 10 and 14
|
14 weeks
|
24 Hour Mean Blood Glucose
Time Frame: 17 weeks
|
Change in 24 mean blood glucose at multiple time points
|
17 weeks
|
Blood Glucose Time In Range
Time Frame: 14 weeks
|
Measure the proportion of time patients who had plasma glucose measurements of: <70 mg/dL, >70 mg/dL and <180 mg/dL or >180 mg/dL
|
14 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Obesity Agents
- Incretins
- Sodium-Glucose Transporter 2 Inhibitors
- Dapagliflozin
- Exenatide
Other Study ID Numbers
- WCCR-2019-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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