A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650

Intarcia Therapeutics

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Other: ITCA placebo; Drug: ITCA 650

Study type: Interventional

Funder types: Industry

Identifiers

NCT01455896

ITCA 650-CLP-107

Details and patient eligibility

About

Phase 3 study to Evaluate cardiovascular outcomes in patients with type 2 diabetes treated with ITCA 650.

Enrollment: 4,156 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HBA1c > 6.5%
• History of coronary, cerebrovascular or peripheral artery disease

Exclusion criteria

• history of pancreatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

4,156 participants in 2 patient groups

ITCA 650 60 mcg/day

Experimental group

Description:

ITCA 650 is exenatide in DUROS

Treatment:

Drug: ITCA 650

ITCA placebo

Other group

Treatment:

Other: ITCA placebo