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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: ITCA placebo; Drug: ITCA 650

• Registration Number: NCT01455896
• Lead Sponsor: Intarcia Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Study Start: 2013-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Disposition First Submitted: 2016-06-03
• Disposition First Submitted QC: 2016-06-03
• Disposition First Posted: 2016-06-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4156

Inclusion Criteria

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

Exclusion Criteria

• history of pancreatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITCA placebo	ITCA placebo	-
ITCA 650 60 mcg/day	ITCA 650	ITCA 650 is exenatide in DUROS

Primary Outcome Measures

Name	Time	Method
time to first occurrence of any event included in the MACE cardiovascular composite endpoint (CV death, non fatal MI, non fatal stroke, or hospitalization for unstable angina),	2 years

Trial Locations

Locations (3)

Study SIte; 🇺🇸 San Diego, California, United States

Study Site; 🇺🇸 San Antonio, Texas, United States

Intarcia Therapeutics, Inc; 🇺🇸 Hayward, California, United States