A Study to Evaluate ITCA 650 Compared to Sitagliptin for the Treatment of Type 2 Diabetes

NCT01455909 · Withdrawn

Last updated 2026-05-28

This study tested a new diabetes treatment called ITCA 650 against the existing drug sitagliptin in adults with type 2 diabetes to see how well it lowered HbA1c 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Status Withdrawn Stopped before any participant enrolled.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 NCT01455909 ↗

Description as written by the study sponsor.

Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.

Treatments tested

ITCA 650 60 mcg/day Drug

exenatide in DUROS
sitagliptin Drug

sitagliptin oral 100 mg/day

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 NCT01455909 ↗