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

Phase 3

Withdrawn

• Conditions: Type 2 Diabetes
• Interventions: Drug: ITCA 650 60 mcg/day; Drug: glimepiride

• Registration Number: NCT01455883
• Lead Sponsor: Intarcia Therapeutics

Brief Summary

Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-21
• Last Update Posted: 2012-12-25
• Study Start: 2013-02
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• HbA1c between 7.5% - 10.5%
• on metformin monotherapy
• BMI between 25 & 45 kg/m2

Exclusion Criteria

• on thiazolidinedione, sulfonylureas, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
• history of pancreatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITCA 650 60 mcg/day	ITCA 650 60 mcg/day	ITCA 650 is exenatide in DUROS
glimepiride	glimepiride	glimepiride up-titrated to 8 mg/day over first 13 weeks

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	52 weeks	52-Week Treatment Period

Trial Locations

Locations (1)

Intarcia Therapeutics, Inc; 🇺🇸 Hayward, California, United States