- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01455922
A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes
December 21, 2012 updated by: Intarcia Therapeutics
A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
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
-
-
California
-
Hayward, California, United States, 94545
- Intarcia Therapeutics, Inc
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- HbA1c between 7.5% - 10.5%
- on metformin monotherapy
- BMI between 25 & 45 kg/m2
Exclusion Criteria:
- On thiazolidinedione, sulfonylurea, DPP-4, alpha glucosidase inhibitor, meglitinides or insulin within last 3 months
- history of pancreatitis
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ITCA 650 60 mcg/day
|
ITCA 650 is exenatide in DUROS
|
Active Comparator: glimepiride
|
glimepiride will be up-titrated to 8 mg/day over first 13 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HbA1c
Time Frame: 52 weeks
|
52-week Treatment Period followed by 52-week Extension Period
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2013
Primary Completion (Anticipated)
July 1, 2014
Study Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
October 18, 2011
First Submitted That Met QC Criteria
October 19, 2011
First Posted (Estimate)
October 20, 2011
Study Record Updates
Last Update Posted (Estimate)
December 25, 2012
Last Update Submitted That Met QC Criteria
December 21, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Anti-Arrhythmia Agents
- Immunosuppressive Agents
- Immunologic Factors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Obesity Agents
- Incretins
- Glimepiride
- Exenatide
Other Study ID Numbers
- ITCA 650-CLP-112
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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