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

Phase 3

Completed

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

• Registration Number: NCT01455870
• Lead Sponsor: Intarcia Therapeutics

Brief Summary

Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy 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
• Study Start: 2013-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-05
• Disposition First Submitted: 2016-05-13
• Disposition First Submitted QC: 2016-05-13
• Last Update Submitted: 2016-05-13
• Disposition First Posted: 2016-06-02
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 535

Inclusion Criteria

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

Exclusion Criteria

• taking thiazolidinedione, sulfonylurea, 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
sitagliptin	sitagliptin	sitagliptin 100 mg/day

Primary Outcome Measures

Name	Time	Method
Change in HbA1c between Week 52 and Day 0	52 weeks