A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes

NCT01455870 · Completed

Last updated 2026-05-28

This clinical trial tested ITCA 650, a new diabetes medication, against sitagliptin in adults with type 2 diabetes to see how well it lowers blood sugar over one year.

Status Completed The study has finished.

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

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 535 people

Who can join Ages 18–80 · all sexes

Timeline Started 2013-05 · est. completion 2015-07

Where 54 sites · Croatia, Denmark, Germany, Latvia, United States

What this study is testing ClinicalTrials.gov NCT01455870 ↗

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

oral sitagliptin 100 mg/day

Main thing measured	Change in HbA1c between Week 52 and Day 0
Sponsor	Intarcia Therapeutics
Conditions studied	Type 2 Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01455870 ↗