Study Stopped
Decision by Sponsor
A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c
An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c
1 other identifier
interventional
100
1 country
51
Brief Summary
An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c \>10% \</=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes
Started May 2013
Longer than P75 for phase_3 type-2-diabetes
51 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
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
February 7, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedMarch 7, 2019
March 1, 2019
4.7 years
February 5, 2013
March 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c between Week 39 and Day 0
39 weeks
Study Arms (1)
ITCA 650
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Men or women age 18 to 80 years with type 2 diabetes
- On stable treatment regimen of diet and exercise alone or in combination with a stable \& optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs
- HbA1c \>10.0% and ≤12.0%
You may not qualify if:
- Prior treatment with any GLP-1 receptor agonist
- History of hypersensitivity to exenatide or liraglutide
- FPG \>300 mg/dL
- History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
- Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
- history of pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235, United States
Fundamental Research
Gulf Shores, Alabama, 36542, United States
East Valley Family Physicians, PLC
Chandler, Arizona, 85224, United States
Desert Clinical Research
Mesa, Arizona, 85213, United States
Clinical Research Advantage, Inc.
Phoenix, Arizona, 85020, United States
eStudySite
Chula Vista, California, United States
Rocks Medical Research Institute, Inc.
Fresno, California, 93721, United States
Rocks Medical Research Institute
Fresno, California, 93721, United States
Long Beach Center for Clinical Research
Long Beach, California, 90807, United States
Saviers Medical Group
Port Hueneme, California, 93041, United States
University Clinical Investigatons, Inc/Diabetes Research Center
Tustin, California, 92780, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Colorado Springs Health Partners-Briargate
Colorado Springs, Colorado, 80922, United States
Meridien Research
Bradenton, Florida, 34208, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216, United States
New Horizon Research Center, Inc.
Miami, Florida, 33175, United States
International Research Assocaites, LLC
Miami, Florida, 33183, United States
Harmony Clinical Research, Inc.
North Miami Beach, Florida, 33162, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, 34684, United States
Andres Patron, D.O., P.A.
Pembroke Pines, Florida, 33026, United States
Clinical Research of West Florida
Tampa, Florida, 33603, United States
Perimeter Institute for Clinical Research PRIME
Atlanta, Georgia, 30338, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Chicago Research Center
Chicago, Illinois, 60634, United States
American Health Network of Indiana, LLC
Avon, Indiana, 46123, United States
Medisphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
American Health Network of Indiana
Franklin, Indiana, 46131, United States
American Health Network of Indiana, LLC
Muncie, Indiana, 47304, United States
Bunyan Clinical Research
Valparaiso, Indiana, 46383, United States
Crescent City Clinical Research Center
Metairie, Louisiana, 70006, United States
Palm Research Center, Inc.
Las Vegas, Nevada, 89148, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209, United States
University of North Carolina at Chapel Hill
Durham, North Carolina, 27713, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, 28144, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Sentral Clinical Research Services, LLC
Cincinnati, Ohio, 45236, United States
Columbus Clinical Research
Columbus, Ohio, 43213, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Lynn Institute of Norman
Norman, Oklahoma, 73069, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Unknown Facility
Greer, South Carolina, 29651, United States
BMG The Endocrine Clinic
Memphis, Tennessee, 38119, United States
Tekton Research, Inc.
Austin, Texas, 78745, United States
3rd Coast Research Associates
Corpus Christi, Texas, 78414, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230, United States
Galena Research
Dallas, Texas, 75251, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Medstar Clinical Research and Associates
Houston, Texas, 77083, United States
Clinical Trials of Texas, Inc.
San Angelo, Texas, 78229, United States
Sound Healthcare
Port Orchard, Washington, 98366, United States
Ranier Clinical Research Center
Renton, Washington, 98057, United States
Related Publications (1)
Henry RR, Rosenstock J, Denham DS, Prabhakar P, Kjems L, Baron MA. Clinical Impact of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Uncontrolled Type 2 Diabetes and Very High Baseline HbA1c: The FREEDOM-1 HBL (High Baseline) Study. Diabetes Care. 2018 Mar;41(3):613-619. doi: 10.2337/dc17-1519. Epub 2018 Jan 4.
PMID: 29301824DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2013
First Posted
February 7, 2013
Study Start
May 1, 2013
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
March 7, 2019
Record last verified: 2019-03