Clinical Drug Experience Knowledgebase

Criteria

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.