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A Study to Evaluate ITCA 650 Compared to Glimepiride for the Treatment of Type 2 Diabetes

NCT ID: NCT01455883

Last Updated: 2012-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ITCA 650 60 mcg/day

ITCA 650 is exenatide in DUROS

Group Type EXPERIMENTAL

ITCA 650 60 mcg/day

Intervention Type DRUG

exenatide in DUROS

glimepiride

glimepiride up-titrated to 8 mg/day over first 13 weeks

Group Type ACTIVE_COMPARATOR

glimepiride

Intervention Type DRUG

oral glimepiride does-escalated,if tolerated, to 8 mg/day

Interventions

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ITCA 650 60 mcg/day

exenatide in DUROS

Intervention Type DRUG

glimepiride

oral glimepiride does-escalated,if tolerated, to 8 mg/day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intarcia Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Intarcia Therapeutics, Inc

Hayward, California, United States

Site Status

Countries

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United States

Other Identifiers

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ITCA 650-CLP-106

Identifier Type: -

Identifier Source: org_study_id