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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Status: Withdrawn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

Page last updated: August 20, 2015

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