- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01798264
Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes
April 5, 2013 updated by: Intarcia Therapeutics
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
evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami Gardens, Florida, United States, 33169
-
-
Ohio
-
Cincinnati, Ohio, United States, 45212
- Medpace Clinical Pharmacology Unit
-
-
Texas
-
San Antonio, Texas, United States, 78229
- DGD Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- type 2 diabetes >6 months
- stable diet & exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0%
Exclusion Criteria:
- prior treatment with exenatide
- history of pancreatitis
- history of medullary thyroid cancer or multiple endocrine neoplasia 2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 10 mcg./day
ITCA 650 (exenatide in DUROS)
|
|
Experimental: 20 mcg/day
ITCA 650 (exenatide in DUROS)
|
|
Experimental: 40 mcg/day
ITCA 650 (exenatide in DUROS)
|
|
Experimental: 80 mcg/day
ITCA 650 (exenatide in DUROS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Subjects With Study Drug-Related Adverse Events
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
Time Frame: 4 weeks
|
Change in HbA1c from baseline
|
4 weeks
|
Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline
Time Frame: 4 weeks
|
4 weeks
|
|
Change in Weight From Baseline to 4 Weeks
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
February 20, 2013
First Submitted That Met QC Criteria
February 22, 2013
First Posted (Estimate)
February 25, 2013
Study Record Updates
Last Update Posted (Estimate)
May 17, 2013
Last Update Submitted That Met QC Criteria
April 5, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITCA 650-CLP-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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