A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c

Intarcia Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: ITCA 650 (exenatide in DUROS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01785771

ITCA 650-CLP-103-Sub-Study

Details and patient eligibility

About

An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women age 18 to 80 years with type 2 diabetes
• On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs
• HbA1c >10.0% and ≤12.0%

Exclusion criteria

• Prior treatment with any GLP-1 receptor agonist
• History of hypersensitivity to exenatide or liraglutide
• FPG >300 mg/dL
• History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
• Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
• history of pancreatitis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

ITCA 650

Experimental group

Treatment:

Drug: ITCA 650 (exenatide in DUROS)