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A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c

OverviewStructured DataIssuesContributors

Contents

clinicaltrials.gov/study/NCT01785771
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT017857710
Health Conditions in Trial
‌
Type 2 Diabetes
0
Trial Recruitment Size
1000
Trial Sponsor
Intarcia Therapeutics
Intarcia Therapeutics
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Clinical Trial Start Date
2013
0
Primary Completion Date
2018
0
Study Completion Date
2018
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
ITCA 650 (exenatide in DUROS)0
Interventional Trial Phase
Phase 30
Participating Facility
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
0
‌
Chicago Research Center
0
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Preferred Primary Care Physicians
0
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Medisphere Medical Research Center, Llc
0
Clinical Trials Of Texas, Inc.
Clinical Trials Of Texas, Inc.
0
Meridien Research
Meridien Research
0
Estudysite
Estudysite
0
University of North Carolina at Chapel Hill
University of North Carolina at Chapel Hill
0
Official Name
An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c0
Last Updated
March 7, 2019
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study summary

An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c \>10% \</=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day

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