Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin

NCT03060980 · Terminated

Last updated 2026-05-28

This clinical trial compared the effects of ITCA 650, empagliflozin, and glimepiride—all added to metformin—in adults with type 2 diabetes.

Status Terminated Stopped early and will not restart.

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

Type Interventional (clinical trial)

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

Participants 245 people

Who can join Ages 18–80 · all sexes

Timeline Started 2017-03 · est. completion 2018-01

Where 101 sites · Canada, United States

What this study is testing ClinicalTrials.gov NCT03060980 ↗

Description as written by the study sponsor.

A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.

Treatments tested

ITCA 650 20/60 mcg/day Drug

ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
Empagliflozin (oral) Drug

10 mg/day and 25 mg/day
Glimepiride (oral) Drug

1-6 mg/day

Main thing measured	Reduction in glycosylated hemoglobin A1c
Sponsor	Intarcia Therapeutics
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03060980 ↗