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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT01455857

Run by

Intarcia Therapeutics

People needed

460

Starts

2013-03-01

Expected to finish

2014-09-01

Last updated by the study team

2015-08-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• taking DPP-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
• history of pancreatitis

Where it is running

• Study Site — Gulf Shores, Alabama, United States
• Study Site — Huntsville, Alabama, United States
• Study Site — Chandler, Arizona, United States
• Study Site — Goodyear, Arizona, United States
• Study Site — Phoenix, Arizona, United States
• Study Site — Little Rock, Arkansas, United States
• Study Site — Chula Vista, California, United States
• Study Site — Fresno, California, United States
• Intarcia — Hayward, California, United States
• Study Site — Long Beach, California, United States
• Study Site — Los Angeles, California, United States
• Study Site — National City, California, United States
• Study Site — Port Hueneme, California, United States
• Study Site — San Jose, California, United States
• Study Site — San Mateo, California, United States
• Study Site — Tustin, California, United States
• Study Site — Valley Village, California, United States
• Study Site — Walnut Creek, California, United States
• Study Site — Watsonville, California, United States
• Study Site — Colorado Springs, Colorado, United States
• Study Site — Colorado Springs, Colorado, United States
• Study Site — Boca Raton, Florida, United States
• Study Site — Bradenton, Florida, United States
• Study Site — Celebration, Florida, United States
• Study Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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