Overview

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

Summary

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
Arm
(Experimental)
itca 650 (exenatide in duros)

Primary Outcomes

Measure
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.