A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes
Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes
1 other identifier
interventional
460
1 country
121
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Mar 2013
121 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedAugust 18, 2015
July 1, 2015
1.4 years
October 18, 2011
July 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
39-week Treatment Period
39 weeks
Study Arms (3)
ITCA 650 40 mcg/day
EXPERIMENTALITCA 650 60 mcg/day
EXPERIMENTALITCA placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (121)
Study Site
Birmingham, Alabama, 35235, United States
Study Site
Gulf Shores, Alabama, 36542, United States
Study Site
Huntsville, Alabama, 35801, United States
Study Site
Chandler, Arizona, 85224, United States
Study Site
Goodyear, Arizona, 85395, United States
Study Site
Phoenix, Arizona, 85020, United States
Study Site
Little Rock, Arkansas, 72205, United States
Study Site
Chula Vista, California, 91911, United States
Study Site
Fresno, California, 93721, United States
Intarcia
Hayward, California, 94545, United States
Study Site
Long Beach, California, 90806, United States
Study Site
Los Angeles, California, 90017, United States
Study Site
National City, California, 91950, United States
Study Site
Port Hueneme, California, 93041, United States
Study Site
San Jose, California, 95123, United States
Study Site
San Mateo, California, 94401, United States
Study Site
Tustin, California, 92780, United States
Study Site
Valley Village, California, 91607, United States
Study Site
Walnut Creek, California, 94598, United States
Study Site
Watsonville, California, 95076, United States
Study Site
Colorado Springs, Colorado, 80907, United States
Study Site
Colorado Springs, Colorado, 80922, United States
Study Site
Boca Raton, Florida, 33432, United States
Study Site
Bradenton, Florida, 34208, United States
Study Site
Celebration, Florida, 34747, United States
Study Site
Clearwater, Florida, 33765, United States
Study Site
Coral Gables, Florida, 33134, United States
Study Site
Daytona Beach, Florida, 32117, United States
Study Site
Hollywood, Florida, 33021, United States
Study Site
Jacksonville, Florida, 32205, United States
Study Site
Jacksonville, Florida, 32216, United States
Study Site
Jacksonville, Florida, 32258, United States
Study Site
Miami, Florida, 33126, United States
Study Site
Miami, Florida, 33135, United States
Study Site
Miami, Florida, 33145, United States
Study Site
Miami, Florida, 33175, United States
Study Site
Miami, Florida, 33183, United States
Study Site
New Port Richey, Florida, 34652, United States
Study Site
North Miami Beach, Florida, 33162, United States
Study Site
Orlando, Florida, 32806, United States
Study Site
Palm Harbor, Florida, 34684, United States
Study Site
Pembroke Pines, Florida, 33026, United States
Study Site
Ponte Vedra, Florida, 32081, United States
Study Site
Tampa, Florida, 33603, United States
Study Site
Atlanta, Georgia, 30338, United States
Study Site
Canton, Georgia, 30114, United States
Study Site
Idaho Falls, Idaho, 83404, United States
Study Site
Meridian, Idaho, 83646, United States
Study Site
Chicago, Illinois, 60607, United States
Study Site
Chicago, Illinois, 60634, United States
Study Site
Chicago, Illinois, 75251, United States
Study Site
Evansville, Illinois, 47714, United States
Study Site
Avon, Indiana, 46123, United States
Study Site
Evansville, Indiana, 47714, United States
Study Site
Franklin, Indiana, 46131, United States
Study Site
Greenfield, Indiana, 46140, United States
Study Site
Muncie, Indiana, 47304, United States
Study Site
Valparaiso, Indiana, 46383, United States
Study Site
Des Moines, Iowa, 50314, United States
Study Site
Newton, Kansas, 67114, United States
Study Site
Metaire, Louisiana, 70006, United States
Study Site
Metairie, Louisiana, 70006, United States
Study Site
Metarie, Louisiana, 70006, United States
Study Site
New Orleans, Louisiana, 70119, United States
Study Site
Baltimore, Maryland, 21204, United States
Study Site
Brockton, Massachusetts, 02301, United States
Study Site
Rochester, Michigan, 48307, United States
Study Site
Ypsilanti, Michigan, 48197, United States
Study Site
Kansas City, Missouri, 64111, United States
Study Site
Billings, Montana, 59101, United States
Study Site
Lincoln, Nebraska, 68510, United States
Study Site
Las Vegas, Nevada, 89148, United States
Study Site
Toms River, New Jersey, 08753, United States
Study Site
Brooklyn, New York, 11218, United States
Study Site
Endwell, New York, 13760, United States
Study Site
Staten Island, New York, 10301, United States
Study Site
Charlotte, North Carolina, 28209, United States
Study Site
Charlotte, North Carolina, 28210, United States
Study Site
Durham, North Carolina, 27713, United States
Study Site
Greensboro, North Carolina, 27401, United States
Study Site
Hickory, North Carolina, 28602, United States
Study Site
Moorehead City, North Carolina, 28557, United States
Study Site
Mooresville, North Carolina, 28117, United States
Study Site
Salisbury, North Carolina, 28144, United States
Study Site
Wilmington, North Carolina, 28401, United States
Study Site
Winston-Salem, North Carolina, 27103, United States
Study Site
Cincinnati, Ohio, 45236, United States
Study Site
Cincinnati, Ohio, 45242, United States
Study Site
Columbus, Ohio, 43213, United States
Study Site
Franklin, Ohio, 45005, United States
Study Site
Toledo, Ohio, 43623, United States
Study Site
Norman, Oklahoma, 73069, United States
Study Site
Oklahoma City, Oklahoma, 73112, United States
Study Site
Bend, Oregon, 97701, United States
Study Site
Uniontown, Pennsylvania, 15401, United States
Study Site
Greer, South Carolina, 29651, United States
Study Site
North Myrtle Beach, South Carolina, 29582, United States
Study Site
Dakota Dunes, South Dakota, 57049, United States
Study Site
Knoxville, Tennessee, 37920, United States
Study Site
Memphis, Tennessee, 38119, United States
Study Site
Austin, Texas, 78731, United States
Study Site
Austin, Texas, 78745, United States
Study Site
Carrolton, Texas, 75007, United States
Study Site
Corpus Cristi, Texas, 78414, United States
Study Site
Dallas, Texas, 75230, United States
Study Site
Dallas, Texas, 75251, United States
Study Site
Fort Worth, Texas, 76135, United States
Study Site
Houston, Texas, 77057, United States
Study Site
Houston, Texas, 77083, United States
Study Site
Houston, Texas, 77095, United States
Study Site
San Angelo, Texas, 76904, United States
Study Site
San Antonio, Texas, 78228, United States
Study Site
San Antonio, Texas, 78229, United States
Study Site
Sugar Land, Texas, 77478, United States
Study Site
Tomball, Texas, 77375, United States
Study Site
Danville, Virginia, 24541, United States
Study Site
Norfolk, Virginia, 23510, United States
Study Site
Richmond, Virginia, 23219, United States
Study Site
Port Orchard, Washington, 98336, United States
Study Site
Renton, Washington, 98057, United States
Study Site
Spokane, Washington, 99202, United States
Related Publications (1)
Rosenstock J, Buse JB, Azeem R, Prabhakar P, Kjems L, Huang H, Baron MA. Efficacy and Safety of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Type 2 Diabetes Uncontrolled With Oral Antidiabetes Drugs: The FREEDOM-1 Trial. Diabetes Care. 2018 Feb;41(2):333-340. doi: 10.2337/dc17-1306. Epub 2017 Dec 14.
PMID: 29242349DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2011
First Posted
October 20, 2011
Study Start
March 1, 2013
Primary Completion
August 1, 2014
Study Completion
September 1, 2014
Last Updated
August 18, 2015
Record last verified: 2015-07