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

I

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

Trial contacts and locations

42

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Data sourced from clinicaltrials.gov

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