ITCA 650-CLP-203 Efficacy of ITCA 650 in Type 2 Diabetes
Research type
Research Study
Full title
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
IRAS ID
219055
Contact name
Melanie Davies
Contact email
Sponsor organisation
Intarcia Inc.
Eudract number
2016-001165-88
Duration of Study in the UK
2 years, 0 months, 12 days
Research summary
This is a phase 3B, randomised, active comparator, open label study to compare the efficacy and safety of ITCA 650 to Empagliflozin and to Glimepiride as an add on therapy to Metformin in patients with Type 2 Diabetes.
ITCA 650 is a small cylinder made of the metal titanium. The cylinder contains exenatide which is a drug which helps control blood glucose levels. The cylinder is about 1¾ inches (44 millimeters) long and about 1/8 inch (4 millimeters) wide. ITCA 650 delivers a certain amount of exenatide to the body every day for as long as it is in place. This can be for up to 6 months. The ITCA 650 device is placed just under the skin of the abdomen (lower part of the stomach).
This is a Global Study with approximately 930 patients being enrolled. The duration of each patient’s participation will be approximately 73 weeks; including screening (between Day -28 and Day -2), a treatment period of 65 weeks duration, and a follow-up visit 4 weeks after the last day of study treatment at Week 65.
Patients will be required to participate in 9 visits to the study site, including 1 Screening Visit, 7 treatment period visits over 65 weeks, and 1 Follow-up Visit 4 weeks after the last day of study treatment.
Patients who meet all inclusion/exclusion criteria will report to the study centre on Day 0 for tests and assessments. Patients will be randomised in a 1:1:1 ratio (approximately 310 patients per arm) to receive either:
ITCA 650 20 mcg/day device for 13 weeks, then ITCA 650 60 mcg/day device for 52 weeks.
or
Empagliflozin (25 mg/day),or
Glimepiride (beginning at 1 mg/day titrated up to a maximum tolerated dose up to 6 mg/day.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
17/EM/0190
Date of REC Opinion
1 Aug 2017
REC opinion
Further Information Favourable Opinion