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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT01455857
First received: October 18, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes
Drug: ITCA 650
Other: ITCA placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Intarcia Therapeutics:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
    39-week Treatment Period


Estimated Enrollment: 450
Study Start Date: March 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ITCA 650 40 mcg/day Drug: ITCA 650
ITCA 650 is exenatide in DUROS
Experimental: ITCA 650 60 mcg/day Drug: ITCA 650
ITCA 650 is exenatide in DUROS
Placebo Comparator: ITCA placebo Other: ITCA placebo
Formulation in DUROS (no exenatide)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HbA1c between 7.5% - 10%
  • On diet & exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU
  • BMI between 25 & 45 kg/m2

Exclusion Criteria:

  • taking DPP-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
  • history of pancreatitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455857

  Hide Study Locations
Locations
United States, Alabama
Study Site
Birmingham, Alabama, United States, 35235
Study Site
Gulf Shores, Alabama, United States, 36542
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Huntsville, Alabama, United States, 35801
United States, Arizona
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Chandler, Arizona, United States, 85224
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Goodyear, Arizona, United States, 85395
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Phoenix, Arizona, United States, 85020
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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Chula Vista, California, United States, 91911
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Fresno, California, United States, 93721
Intarcia
Hayward, California, United States, 94545
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Long Beach, California, United States, 90806
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Los Angeles, California, United States, 90017
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National City, California, United States, 91950
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Port Hueneme, California, United States, 93041
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San Jose, California, United States, 95123
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San Mateo, California, United States, 94401
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Tustin, California, United States, 92780
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Valley Village, California, United States, 91607
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Walnut Creek, California, United States, 94598
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Watsonville, California, United States, 95076
United States, Colorado
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Colorado Springs, Colorado, United States, 80907
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Colorado Springs, Colorado, United States, 80922
United States, Florida
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Boca Raton, Florida, United States, 33432
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Bradenton, Florida, United States, 34208
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Celebration, Florida, United States, 34747
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Clearwater, Florida, United States, 33765
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Coral Gables, Florida, United States, 33134
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Daytona Beach, Florida, United States, 32117
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32258
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Jacksonville, Florida, United States, 32205
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Jacksonville, Florida, United States, 32216
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Miami, Florida, United States, 33145
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Miami, Florida, United States, 33135
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Miami, Florida, United States, 33126
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Miami, Florida, United States, 33175
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Miami, Florida, United States, 33183
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N. Miami Beach, Florida, United States, 33162
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New Port Richey, Florida, United States, 34652
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North Miami Beach, Florida, United States, 33162
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Orlando, Florida, United States, 32806
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Palm Harbor, Florida, United States, 34684
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Pembroke Pines, Florida, United States, 33026
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Ponte Vedra, Florida, United States, 32081
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Tampa, Florida, United States, 33603
United States, Georgia
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Atlanta, Georgia, United States, 30338
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Canton, Georgia, United States, 30114
United States, Idaho
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Idaho Falls, Idaho, United States, 83404
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Meridian, Idaho, United States, 83646
United States, Illinois
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Chicago, Illinois, United States, 60634
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Chicago, Illinois, United States, 60607
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Chicago, Illinois, United States, 75251
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Evansville, Illinois, United States, 47714
United States, Indiana
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Avon, Indiana, United States, 46123
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Evansville, Indiana, United States, 47714
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Franklin, Indiana, United States, 46131
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Greenfield, Indiana, United States, 46140
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Muncie, Indiana, United States, 47304
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Valparaiso, Indiana, United States, 46383
United States, Iowa
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Des Moines, Iowa, United States, 50314
United States, Kansas
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Newton, Kansas, United States, 67114
United States, Louisiana
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Metaire, Louisiana, United States, 70006
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Metairie, Louisiana, United States, 70006
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Metarie, Louisiana, United States, 70006
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New Orleans, Louisiana, United States, 70119
United States, Maryland
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Baltimore, Maryland, United States, 21204
United States, Massachusetts
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Brockton, Massachusetts, United States, 02301
United States, Michigan
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Rochester, Michigan, United States, 48307
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Ypsilanti, Michigan, United States, 48197
United States, Missouri
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Kansas City, Missouri, United States, 64111
United States, Montana
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Billings, Montana, United States, 59101
United States, Nebraska
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Lincoln, Nebraska, United States, 68510
United States, Nevada
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Las Vegas, Nevada, United States, 89148
United States, New Jersey
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Toms RIver, New Jersey, United States, 08753
United States, New York
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Brooklyn, New York, United States, 11218
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Endwell, New York, United States, 13760
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Staten Island, New York, United States, 10301
United States, North Carolina
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Charlotte, North Carolina, United States, 28210
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Charlotte, North Carolina, United States, 28209
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Durham, North Carolina, United States, 27713
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Greensboro, North Carolina, United States, 27401
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Hickory, North Carolina, United States, 28602
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Moorehead City, North Carolina, United States, 28557
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Mooresville, North Carolina, United States, 28117
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Salisbury, North Carolina, United States, 28144
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Wilmington, North Carolina, United States, 28401
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Cincinnati, Ohio, United States, 45242
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Cincinnati, Ohio, United States, 45236
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Columbus, Ohio, United States, 43213
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Franklin, Ohio, United States, 45005
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Toledo, Ohio, United States, 43623
United States, Oklahoma
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Norman, Oklahoma, United States, 73069
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Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
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Bend, Oregon, United States, 97701
United States, Pennsylvania
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Uniontown, Pennsylvania, United States, 15401
United States, South Carolina
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Greer, South Carolina, United States, 29651
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N. Myrtle Beach, South Carolina, United States, 29582
United States, South Dakota
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Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
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Knoxville, Tennessee, United States, 37920
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Memphis, Tennessee, United States, 38119
United States, Texas
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Austin, Texas, United States, 78731
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Austin, Texas, United States, 78745
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Carrolton, Texas, United States, 75007
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Corpus Cristi, Texas, United States, 78414
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Dallas, Texas, United States, 75230
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Dallas, Texas, United States, 75251
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Fort Worth, Texas, United States, 76135
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Houston, Texas, United States, 77083
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Houston, Texas, United States, 77095
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Houston, Texas, United States, 77057
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San Angelo, Texas, United States, 76904
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San Antonio, Texas, United States, 78228
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San Antonio, Texas, United States, 78229
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Sugar Land, Texas, United States, 77478
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Tomball, Texas, United States, 77375
United States, Virginia
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Danville, Virginia, United States, 24541
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Norfolk, Virginia, United States, 23510
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Richmond, Virginia, United States, 23219
United States, Washington
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Port Orchard, Washington, United States, 98336
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Renton, Washington, United States, 98057
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Spokane, Washington, United States, 99202
Sponsors and Collaborators
Intarcia Therapeutics
  More Information

No publications provided

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT01455857     History of Changes
Other Study ID Numbers: ITCA 650-CLP-103
Study First Received: October 18, 2011
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014