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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: ITCA 650; Other: ITCA placebo

• Registration Number: NCT01455857
• Lead Sponsor: Intarcia Therapeutics

Brief Summary

Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy 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: 2011-10-18
• Study First Posted: 2011-10-20
• Study Start: 2013-03
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2015-07
• Disposition First Submitted: 2015-07-28
• Disposition First Submitted QC: 2015-07-28
• Last Update Submitted: 2015-07-28
• Disposition First Posted: 2015-08-18
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

• HbA1c between 7.5% - 10%
• On diet & exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU
• BMI between 25 & 45 kg/m2

Exclusion Criteria

• taking DPP-4 inhibitors, exenatide, liraglutide, 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	-
ITCA placebo	ITCA placebo	-
ITCA 650 40 mcg/day	ITCA 650	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	39 weeks	39-week Treatment Period

Trial Locations

Locations (2)

Study Site; 🇺🇸 Spokane, Washington, United States

Intarcia; 🇺🇸 Hayward, California, United States