Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide

NCT02638805 · Completed

Last updated 2026-05-28

This clinical trial tests the safety and tolerability of switching from liraglutide to ITCA 650 in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 136 people

Who can join Ages 18–80 · all sexes

Timeline Started 2015-12 · est. completion 2017-10

Where 36 sites · United States

What this study is testing ClinicalTrials.gov NCT02638805 ↗

Description as written by the study sponsor.

A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.

Treatments tested

ITCA 650 Osmotic Mini Pump 20/60 mcg/day Drug

ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day
ITCA 650 Osmotic Mini Pump 60 mcg/day Drug

ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day
Metformin Drug

Stable dose for at least 3 months (at least 1000 mg/day)
Liraglutide Drug

Stable dose for at least 3 months (at least 1.2 mg/day)

Main thing measured	Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting
Sponsor	Intarcia Therapeutics
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02638805 ↗