A Study to Evaluate Cardiovascular Outcomes with ITCA 650 in Patients Treated with Standard of Care for Type 2 Diabetes

Phase 1

• Conditions: Type 2 diabetes; MedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-002219-25-ES
• Lead Sponsor: Intarcia Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-09
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3000

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. Patients with understanding of the study procedures and agreement to participate in the study by giving written informed consent in accordance with local regulations and the Institutional Review Board (IRB)/Ethics Committee (EC) governing the study site at or prior to Screening;
6. 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
7. 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
8.Calcitonin <50 pg/mL (ng/L) at Screening;
9. Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception during the study and for one additional menstrual cycle following the End-of-Treatment (ET) Visit.
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

1. Prior treatment with DPP-4 inhibitor or GLP-1 agonist within 3 months prior to Screening; 2. Current treatment with rapid-acting insulin or rapid-acting insulin analogues; 3. Requirement of treatment with immunosuppressants or medications that affect (GI) motility (see Appendix B); 4. Allergic reactions or intolerance to GLP-1 receptor agonists; 5. History of hypersensitivity to exenatide;6. Diagnosis of or history of: Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes, Acute metabolic diabetic complications, major hypoglycemia; 7. History of acute or chronic pancreatitis; 8. Family or personal history of thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2); 9. Presence of a thyroid nodule detected on physical examination that has not been fully evaluated; 10. Thyroid-stimulating hormone (TSH) outside of normal limits at Screening. 11. Thyroid hormone therapy that has not been stable for ?6 weeks prior to Screening; 12. Currently scheduled for cardiac surgery or arterial revascularization (carotid, coronary, or peripheral) procedures; 13. Current New York Heart Association (NYHA) Class III or IV heart failure; 14. 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; 15. Prior history of treatment with an investigational drug within 30 days prior to Screening Visit 1 (Days -28 to -2) 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; 16. Laboratory abnormalities in FPG, ALT, AST, Bilirubin, Fasting triglycerides, GFR described in protocol. Patients taking metformin are excluded if serum creatinine levels are >1.5 mg/dL (132 µmol/L) for males, or >1.4 mg/dL (123 µmol/L) for females; 17. 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); 18. History of positive serologic evidence of current infectious liver disease; 19. Presence of diabetic complications that, in the opinion of the Investigator, would complicate the patient?s participation in the study; 20.History of organ transplantation; 21. Known clinically significant gastric emptying abnormality (see Appendix B); 22. Donation of one unit (500 mL) or more of blood; significant blood loss equaling at least one unit of blood; or transfusion within 8 weeks prior to Screening;23. History or evidence of immunocompromised status; 24. History of active alcohol or substance abuse within 1 year prior to Screening; 25. Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to Screening; intra-nasal, intra-articular, intra-ocular, inhaled or topical steroids are permitted.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified