A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes

NCT ID: NCT01455870

Last Updated: 2016-06-02

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

535 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-07-31

Brief Summary

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Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy 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

sitagliptin

sitagliptin 100 mg/day

Group Type ACTIVE_COMPARATOR

sitagliptin

Intervention Type DRUG

oral sitagliptin 100 mg/day

Interventions

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ITCA 650 60 mcg/day

exenatide in DUROS

Intervention Type DRUG

sitagliptin

oral sitagliptin 100 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

* taking thiazolidinedione, sulfonylurea, 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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Birmingham, Alabama, United States

Site Status

Chandler, Arizona, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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San Mateo, California, United States

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Tustin, California, United States

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Valley Village, California, United States

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Walnut Creek, California, United States

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Boca Raton, Florida, United States

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Clearwater, Florida, United States

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Coral Gables, Florida, United States

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Miami, Florida, United States

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North Miami Beach, Florida, United States

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Pembroke Pines, Florida, United States

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Canton, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Avon, Indiana, United States

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Franklin, Indiana, United States

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Greenfield, Indiana, United States

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Muncie, Indiana, United States

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Valparaiso, Indiana, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Metairie, Louisiana, United States

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Brockton, Massachusetts, United States

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Traverse City, Michigan, United States

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Troy, Michigan, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Brooklyn, New York, United States

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Endwell, New York, United States

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Morehead City, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Kettering, Ohio, United States

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Norman, Oklahoma, United States

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Bend, Oregon, United States

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Uniontown, Pennsylvania, United States

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Memphis, Tennessee, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Tomball, Texas, United States

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Rijeka, , Croatia

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Hvidovre, , Denmark

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Bad Lauterberg im Harz, Lower Saxony, Germany

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Riga, , Latvia

Site Status

Countries

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United States Croatia Denmark Germany Latvia

Other Identifiers

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ITCA 650-CLP-105

Identifier Type: -

Identifier Source: org_study_id

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