NCT03060980

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

A Phase 3b, Randomized, Active Comparator, Open-label, Multicenter Study to Compare the Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Intarcia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	ITCA 650 20/60 mcg/day	ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
DRUG	Empagliflozin (oral)	10 mg/day and 25 mg/day
DRUG	Glimepiride (oral)	1-6 mg/day

Timeline

• Start date: 2017-03-03
• Primary completion: 2018-01-26
• Completion: 2018-01-26
• First posted: 2017-02-23
• Last updated: 2019-03-07

Locations

101 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study