Type 2 diabetes MedDRA version: 17.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: ITCA 650 20 mcg/day
Product Code: ITCA 650 20 mcg/day
Pharmaceutical Form: Implant
INN or Proposed INN: EXENATIDE
CAS Number: 141758-74-9
Concentration unit: µg microgram(s)
Concentrat
Sponsors
Intarcia Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a diagnosis of T2D 2. Patients with HbA1c =6.5% at Screening. 3. High-risk group defined as males and females =40 years old with at least one documented occurrence of: CAD, cerebrovascular disease, or symptomatic peripheral arterial disease whose disease, in the Investigator's opinion, is stable, and not in the acute recovery stage of a CV event (i.e., event listed below to have occurred at LEAST 1 month prior to Screening, unless otherwise specified) 4. Low-risk group defined as males and females =60 years old with at least one other risk factor in addition to T2D 5. Current treatment with an intermediate-acting and / or long-acting insulin or intermediate and / or long-acting insulin analogue is allowed; if the screening HbA1c value is =8.0%, then the total daily dose of intermediate-acting and/or long-acting insulin or intermediate and/or long-acting insulin analogue will be reduced by 20% at randomization 6. Patients who are on a stable treatment regimen of diet and exercise alone or who are being treated with oral monotherapy or oral combination antidiabetic therapy with the exception of a dipeptidylpeptidase-4 (DPP-4) inhibitor or a glucagonlike peptide (GLP)-1 agonist within 12 weeks of randomization. 7. Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception during the study 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 1500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1500
Exclusion criteria
Exclusion criteria: 1. Prior treatment with DPP-4 inhibitor or GLP-1 agonist within 12 weeks of randomization; 2. Current treatment with rapid-acting insulin or rapid-acting insulin analogues; 3. Requirement of treatment with immunosuppressants or medications that affect gastrointestinal (GI) motility (see Appendix C); 4. Diagnosis of or history of: • Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes, e.g., acromegaly and Cushing's Syndrome; • Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within 6 months of randomization; • Major hypoglycemia (defined as requiring third party assistance) within 1 month prior to Screening. 5. History of acute or chronic pancreatitis; 6. Family or personal history of thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2); 7. Presence of a thyroid nodule detected on physical examination that has not been fully evaluated; 8. Currently scheduled for cardiac surgery or arterial revascularization (carotid, coronary, or peripheral) procedures; 9. Current New York Heart Association (NYHA) Class III or IV heart failure; 10. Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years; 11. Uncontrolled hypertension at Screening defined as a systolic BP >180 mmHg and/or a diastolic BP >100 mmHg with or without antihypertensive medication (may be repeated after 15 minutes and exclusion based on last measurement);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of Study 107 is to obtain CV event data that will be pooled with CV event data from other pivotal Phase 3 studies in a meta-analysis to demonstrate that the upper limit of the 95% confidence interval of the hazard ratio of major adverse cardiac events (MACE) in adult patients on Standard of Care for T2D receiving either ITCA 650 or control, based on the time to first occurrence of any event in the MACE1 CV composite endpoint (CV death, non-fatal myocardial infarction [MI], non-fatal stroke, or hospitalization for unstable angina), does not exceed 1.8. ;Secondary Objective: The secondary objective of Study 107 is to use CV event data obtained from Study 107 alone to demonstrate that the upper limit of the 95% confidence interval of the hazard ratio of MACE in adult patients on Standard of Care for T2D receiving either ITCA 650 or control, based on the time to first occurrence of any event in the MACE2 CV composite endpoint that excludes hospitalization for unstable angina (CV death, non-fatal MI, or non-fatal stroke), does not exceed 1.3.;Primary end point(s): Time to first occurrence of any event in the MACE composite endpoint (CV death, non-fatal MI, non-fatal stroke, or hospitalization for unstable angina).;Timepoint(s) of evaluation of this end point: First occurrence of any event in the MACE composite endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to first occurrence of any event in the MACE2 composite endpoint (CV death, non-fatal MI, or non-fatal stroke) ;Timepoint(s) of evaluation of this end point: The first occurrence of any event listed above | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Hungary, India, Israel, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Poland, Romania, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Turkey, Ukraine, United Arab Emirates, United States
Contacts
Public ContactChief Medical Officer
Intarcia Therapeutics, Inc
Outcome results
None listed