A Study to Evaluate ITCA 650 Compared to Glimepiride for the Treatment of Type 2 Diabetes
Information source: Intarcia Therapeutics
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: ITCA 650 60 mcg/day (Drug); glimepiride (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Intarcia Therapeutics
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in HbA1c
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- HbA1c between 7. 5% - 10. 5%
- on metformin monotherapy
- BMI between 25 & 45 kg/m2
Exclusion Criteria:
- on thiazolidinedione, sulfonylureas, DPP-4, exenatide, alpha glucosidase inhibitors,
meglitinides or insulin within last 3 months
- history of pancreatitis
Locations and Contacts
Intarcia Therapeutics, Inc, Hayward, California 94545, United States
Additional Information
Starting date: February 2013
Last updated: December 21, 2012
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