Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes
A Phase Ib, Randomized, Open-Label, Multi-Center, 4-Week Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
44
1 country
3
Brief Summary
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes
Started Feb 2009
Shorter than P25 for phase_1 type-2-diabetes
3 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
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 20, 2013
CompletedFirst Posted
Study publicly available on registry
February 25, 2013
CompletedResults Posted
Study results publicly available
May 17, 2013
CompletedMay 17, 2013
April 1, 2013
3 months
February 20, 2013
February 25, 2013
April 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Study Drug-Related Adverse Events
4 weeks
Secondary Outcomes (3)
To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
4 weeks
Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline
4 weeks
Change in Weight From Baseline to 4 Weeks
4 weeks
Study Arms (4)
10 mcg./day
EXPERIMENTALITCA 650 (exenatide in DUROS)
20 mcg/day
EXPERIMENTALITCA 650 (exenatide in DUROS)
40 mcg/day
EXPERIMENTALITCA 650 (exenatide in DUROS)
80 mcg/day
EXPERIMENTALITCA 650 (exenatide in DUROS)
Interventions
Eligibility Criteria
You may qualify if:
- type 2 diabetes \>6 months
- stable diet \& exercise, metformin, TZD or met + TZD HbA1c \>6.5% \<10.0%
You may not qualify if:
- prior treatment with exenatide
- history of pancreatitis
- history of medullary thyroid cancer or multiple endocrine neoplasia 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Miami Gardens, Florida, 33169, United States
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45212, United States
dGd Research
San Antonio, Texas, 78229, United States
Related Publications (1)
Henry RR, Logan D, Alessi T, Baron MA. A randomized, open-label, multicenter, 4-week study to evaluate the tolerability and pharmacokinetics of ITCA 650 in patients with type 2 diabetes. Clin Ther. 2013 May;35(5):634-645.e1. doi: 10.1016/j.clinthera.2013.03.011. Epub 2013 Apr 8.
PMID: 23578605DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michelle Braon
- Organization
- Intarcia
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2013
First Posted
February 25, 2013
Study Start
February 1, 2009
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
May 17, 2013
Results First Posted
May 17, 2013
Record last verified: 2013-04