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

• Status: Terminated
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c >10%Phase: Phase 3

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intarcia Therapeutics
• Treatments: Exenatide

Criteria

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