Type 2 diabetes MedDRA version: 19.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 19.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: ITCA 650 20 mcg/day
Product Code: ITCA 650
Pharmaceutical Form: Implant
INN or Proposed INN: EXENATIDE
CAS Number: 141758-74-9
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Intarcia Therapeutics, Inc.
Eligibility
Sex/Gender
All
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 = 45 kg/m2 at the Screening Visit. 5. Stable body weight (not varying by >10%) = 3 months prior to the Screening Visit. 6. Glycosylated hemoglobin A1c (HbA1c) =7.5 and =10.5%. One re-test of this parameter is allowed prior to Visit 2. 7. Calcitonin 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 694 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 236
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 Screening Hepatic/Pancreatic/Gastrointestinal 20. History or evidence of acute or chronic pancreatitis 21. History of weight loss surgery 22. History of current infectious liver disease including hepatitis B or hepatitis C virus. Patients wh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin (HbA1c) or weight in patients with type 2 diabetes (T2D) following 65 weeks of treatment. The non-inferiority margins are 0.3% and 1.5 kg, for HbA1c and weight, respectively. If non-inferiority is demonstrated, then ITCA 650 will be tested for corresponding superiority.;Secondary Objective: Following 65 weeks of treatment of either ITCA 650, empagliflozin, or glimepiride: Key secondary objective: - To compare % of patients in each arm with decrease in HbA1c =1.0% and =2 kg weight loss Other secondary objectives: - To compare % of patients in each arm who need rescue and % of patients in each arm achieving treatment to goal defined as HbA1c <7% - To compare % of patients in each arm achieving treatment to goal defined as HbA1c =6.5% - To determine the overall safety and tolerability of ITCA 650 compared with empagliflozin and with glimepiride - To determine the change in fasting plasma glucose in patients on ITCA 650 compared with empagliflozin and glimepiride - Time to rescue will also be conducted using the log-rank test and Kaplan-Meier curve for ITCA vs. empagliflozin and ITCA vs. glimepiride - To characterize treatment satisfaction, as measured by the patient reported outcome questionnaire [DTSQ] with ITCA 650 compared with empagliflozin and with glimepiride;Primary end point(s): PRIMARY EFFICACY ENDPOINTS: Co-primary endpoints: - Change from baseline in HbA1c at Week 65. - Change from baseline in weight at Week 65.;Timepoint(s) of evaluation of this end point: Week 65 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): KEY SECONDARY EFFICACY ENDPOINT - 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 <7% at Week 65. - Percentage of patients with treatment to goal defined as HbA1c =6.5% at Week 65. - Change from baseline in FPG at Week 65. - PROs: DTSQ scores.;Timepoint(s) of evaluation of this end point: Week 65 Exception applicable for: - "Percentage of patients who need rescue during the 65-week period": during the treatment period - "PROs: DTSQ scores": during the treatment period | — |
Countries
Australia, Brazil, Canada, France, Germany, Italy, Korea, Republic of, Netherlands, Russian Federation, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactChief Medical Officer
Intarcia Therapeutics, Inc.
Outcome results
None listed