A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes

NCT01455922 · Withdrawn

Last updated 2026-05-28

This study tested a new diabetes medication called ITCA 650 against glimepiride in adults with type 2 diabetes to see how well it lowers blood sugar levels.

Status Withdrawn Stopped before any participant enrolled.

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

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Who can join Ages 18–80 · all sexes

Timeline Started 2013-02 · est. completion 2014-07

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT01455922 ↗

Description as written by the study sponsor.

Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.

Treatments tested

ITCA 650 Drug

ITCA 650 is exenatide in DUROS
glimepiride Drug

glimepiride will be up-titrated to 8 mg/day over first 13 weeks

Main thing measured	Change in HbA1c
Sponsor	Intarcia Therapeutics
Conditions studied	Type 2 Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01455922 ↗