add on therepy Type 2 Diabetes
Conditions
Interventions
ITCA 650 will be provided as an osmotic mini-pump that delivers 20 or 60
mcg/day exenatide. The 20 mcg/day osmotic mini-pump delivers 20 mcg/day for 3
months. The 60 mcg/day osmotic mini-pump delive
Diabetes Type 2
Sponsors
Intarcia Therapeutics, Inc
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Understanding of the study procedures and conditions of the protocol and agreement to participate in the study by providing a signed and dated informed consent prior to any study-specific procedures. 2. Male or female patients 18 to 80 years old, inclusive. 3. Diagnosis of T2D >= 3 months prior to the Screening Visit. 4. Body mass index (BMI) between >= 25 to 10%) >= 3 months prior to the Screening Visit. 6. Glycosylated hemoglobin A1c (HbA1c) >=7.5 and = 3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of >=1500 mg/day. 9. Agreement to maintain the same dose of background metformin from the Screening Visit to the end of the study (unless a change is clinically indicated). 10. Women may be enrolled if all of the following criteria (in addition to other criteria) are met: they are not pregnant; they are not breast feeding; and they do not plan on becoming pregnant during the study. 11. Women of childbearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit. Women are considered to be of childbearing potential unless they meet one of the following criteria as documented by the Investigator: • They have had a hysterectomy or tubal ligation prior to signing the informed consent form (ICF); or • They are post-menopausal, defined for women = 2 years since their last menstrual period and for women >50 years old as >= 1 year since their last menstrual period. 12. WOCBP must agree to use an adequate method of contraception during the study and for 1 additional menstrual cycle after the Follow-up visit. Women practicing abstinence or whose partner(s) is (are) sterile should be considered to be of childbearing potential. Adequate methods of contraception for WOCBP include: oral, implanted or injectable contraceptive hormones; mechanical products (intrauterine device); or barrier methods (diaphragm, condoms, cervical cap) with spermicide. The patient's understanding of this requirement must be documented by the Investigator.
Exclusion criteria
Exclusion criteria: Diabetes Therapy or History 1. History of type 1 diabetes, diabetes that is the result of pancreatic injury, or secondary forms of diabetes, (eg, Cushing's syndrome) and/or acute metabolic complications such as diabetic ketoacidosis or hyperosmolar state (coma) 2. Participation in a clinical study involving ITCA 650 3. Treatment with any GLP-1 receptor agonist within 6 months prior to Screening or at any time in the past if therapy was discontinued due to gastrointestinal intolerance. This includes treatment during participation in a clinical study 4. Treatment with any of the following antidiabetic agents within 3 months prior to Screening: sodium-glucose cotransporter-2 inhibitors, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha glucosidase inhibitors, meglitinides, thiazolidinediones, bile acid sequestrants (eg, colesevelam), dopamine receptor agonists (eg, bromocriptine), amylin analogues (eg, pramlitide), or insulin. NOTE: History of short term (270 mg/dL (15 mmol/L). One re-test of this parameter is allowed prior to randomization 6. Significant symptomatic hyperglycemia: polyuria, polydipsia, unexplained weight loss History 7. Any condition, clinically significant laboratory abnormality or therapy, which might pose a risk to the patient, or interfere with the conduct of the study or interpretation of the safety and efficacy data 8. Alcohol or substance abuse within 1 year prior to Screening 9. Treatment with an investigational drug within 30 days prior to screening or 5 half-lives (whichever is longer); participation in a clinical study involving an investigational product or non-approved use of a drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study 10. History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients 11. Contraindications or warnings according to the specific labels for metformin, empagliflozin, or glimepiride therapy Endocrine 12. History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2 13. Presence of a thyroid nodule, detected on a physical examination that has not been fully evaluated 14. Thyroid-stimulating hormone outside of normal limits at Screening. One re- test of this parameter is allowed prior to inclusion 15. Thyroid hormone therapy that has not been stable for >=6 weeks prior to Screening Cardiovascular 16. History or evidence, within the last 6 months prior to the Screening Visit, of any of the following: myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, cerebrovascular accident or stroke 17. Uncontrolled hypertension: sitting systolic blood pressure >=180 mmHg and /or sitting diastolic blood pressure >100 mmHg at Screening (may be repeated after 15 minutes and exclusion will be based on the last measurement) 18. Congestive heart failure (Grade III and IV acc. to NYHA classification) Renal 19. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at the Scr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoints: • Change from baseline in HbA1c at Week 65. • Change from baseline in weight at Week 65. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with a decrease in HbA1c >=1.0% and >=2 kg weight loss at Week 65. OTHER SECONDARY EFFICACY ENDPOINTS: • Percentage of patients who need rescue during the 65-week period. • Percentage of patients with treatment to goal defined as HbA1c | — |
Countries
The Netherlands
Outcome results
None listed