A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes
A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
1 other identifier
interventional
535
5 countries
54
Brief Summary
Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy 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 May 2013
Typical duration for phase_3 type-2-diabetes
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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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
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJune 2, 2016
May 1, 2016
2.2 years
October 18, 2011
May 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c between Week 52 and Day 0
52 weeks
Study Arms (2)
ITCA 650 60 mcg/day
EXPERIMENTALITCA 650 is exenatide in DUROS
sitagliptin
ACTIVE COMPARATORsitagliptin 100 mg/day
Interventions
Eligibility Criteria
You may qualify if:
- HbA1c between 7.5% - 10.5%
- on metformin monotherapy
- BMI between 25 \& 45 kg/m2
You may not qualify if:
- taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
- history of pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Unknown Facility
Birmingham, Alabama, 35235, United States
Unknown Facility
Chandler, Arizona, 85224, United States
Unknown Facility
Long Beach, California, 90807, United States
Unknown Facility
Los Angeles, California, 90017, United States
Unknown Facility
San Diego, California, 92101, United States
Unknown Facility
San Mateo, California, 94401, United States
Unknown Facility
Tustin, California, 92780, United States
Unknown Facility
Valley Village, California, 91607, United States
Unknown Facility
Walnut Creek, California, 94598, United States
Unknown Facility
Boca Raton, Florida, 33432, United States
Unknown Facility
Clearwater, Florida, 33765, United States
Unknown Facility
Coral Gables, Florida, 33134, United States
Unknown Facility
Miami, Florida, 33126, United States
Unknown Facility
North Miami Beach, Florida, 33162, United States
Unknown Facility
Pembroke Pines, Florida, 33026, United States
Unknown Facility
Canton, Georgia, 30114, United States
Unknown Facility
Chicago, Illinois, 60607, United States
Unknown Facility
Chicago, Illinois, 60634, United States
Unknown Facility
Avon, Indiana, 46123, United States
Unknown Facility
Franklin, Indiana, 46131, United States
Unknown Facility
Greenfield, Indiana, 46140, United States
Unknown Facility
Muncie, Indiana, 47304, United States
Unknown Facility
Valparaiso, Indiana, 46383, United States
Unknown Facility
Wichita, Kansas, 67205, United States
Unknown Facility
Wichita, Kansas, 67208, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
Brockton, Massachusetts, 2301, United States
Unknown Facility
Traverse City, Michigan, 49684, United States
Unknown Facility
Troy, Michigan, 48098, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Billings, Montana, 59101, United States
Unknown Facility
Lincoln, Nebraska, 68510, United States
Unknown Facility
Las Vegas, Nevada, 89148, United States
Unknown Facility
Brooklyn, New York, 11218, United States
Unknown Facility
Endwell, New York, 13760, United States
Unknown Facility
Morehead City, North Carolina, 28557, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Cincinnati, Ohio, 45227, United States
Unknown Facility
Kettering, Ohio, 45429, United States
Unknown Facility
Norman, Oklahoma, 73069, United States
Unknown Facility
Bend, Oregon, 97701, United States
Unknown Facility
Uniontown, Pennsylvania, 15401, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
Corpus Christi, Texas, 78414, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
Dallas, Texas, 75390, United States
Unknown Facility
Houston, Texas, 77083, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Sugar Land, Texas, 77478, United States
Unknown Facility
Tomball, Texas, 77375, United States
Unknown Facility
Rijeka, 51000, Croatia
Unknown Facility
Hvidovre, 2650, Denmark
Unknown Facility
Bad Lauterberg im Harz, Lower Saxony, 37431, Germany
Unknown Facility
Riga, LV1002, Latvia
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
May 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
June 2, 2016
Record last verified: 2016-05