This trial is active, not recruiting.

Condition type 2 diabetes
Treatment itca 650 (exenatide in duros)
Phase phase 3
Sponsor Intarcia Therapeutics
Start date May 2013
End date August 2017
Trial size 100 participants
Trial identifier NCT01785771, ITCA 650-CLP-103-Sub-Study


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
itca 650 (exenatide in duros)

Primary Outcomes

Change in HbA1c between Week 39 and Day 0
time frame: 39 weeks

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Intarcia Therapeutics.