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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01455870
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : June 2, 2016
Information provided by (Responsible Party):
Intarcia Therapeutics

Brief Summary:
Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: ITCA 650 60 mcg/day Drug: sitagliptin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 535 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Study Start Date : May 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ITCA 650 60 mcg/day
ITCA 650 is exenatide in DUROS
Drug: ITCA 650 60 mcg/day
exenatide in DUROS
Active Comparator: sitagliptin
sitagliptin 100 mg/day
Drug: sitagliptin
oral sitagliptin 100 mg/day

Primary Outcome Measures :
  1. Change in HbA1c between Week 52 and Day 0 [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01455870

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35235
United States, Arizona
Chandler, Arizona, United States, 85224
United States, California
Long Beach, California, United States, 90807
Los Angeles, California, United States, 90017
San Diego, California, United States, 92101
San Mateo, California, United States, 94401
Tustin, California, United States, 92780
Valley Village, California, United States, 91607
Walnut Creek, California, United States, 94598
United States, Florida
Boca Raton, Florida, United States, 33432
Clearwater, Florida, United States, 33765
Coral Gables, Florida, United States, 33134
Miami, Florida, United States, 33126
North Miami Beach, Florida, United States, 33162
Pembroke Pines, Florida, United States, 33026
United States, Georgia
Canton, Georgia, United States, 30114
United States, Illinois
Chicago, Illinois, United States, 60607
Chicago, Illinois, United States, 60634
United States, Indiana
Avon, Indiana, United States, 46123
Franklin, Indiana, United States, 46131
Greenfield, Indiana, United States, 46140
Muncie, Indiana, United States, 47304
Valparaiso, Indiana, United States, 46383
United States, Kansas
Wichita, Kansas, United States, 67205
Wichita, Kansas, United States, 67208
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Brockton, Massachusetts, United States, 2301
United States, Michigan
Traverse City, Michigan, United States, 49684
Troy, Michigan, United States, 48098
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Montana
Billings, Montana, United States, 59101
United States, Nebraska
Lincoln, Nebraska, United States, 68510
United States, Nevada
Las Vegas, Nevada, United States, 89148
United States, New York
Brooklyn, New York, United States, 11218
Endwell, New York, United States, 13760
United States, North Carolina
Morehead City, North Carolina, United States, 28557
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati, Ohio, United States, 45227
Kettering, Ohio, United States, 45429
United States, Oklahoma
Norman, Oklahoma, United States, 73069
United States, Oregon
Bend, Oregon, United States, 97701
United States, Pennsylvania
Uniontown, Pennsylvania, United States, 15401
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Texas
Corpus Christi, Texas, United States, 78414
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75390
Houston, Texas, United States, 77083
San Antonio, Texas, United States, 78229
Sugar Land, Texas, United States, 77478
Tomball, Texas, United States, 77375
Rijeka, Croatia, 51000
Hvidovre, Denmark, 2650
Bad Lauterberg im Harz, Niedersachsen, Germany, 37431
Riga, Latvia, LV1002
Sponsors and Collaborators
Intarcia Therapeutics

Responsible Party: Intarcia Therapeutics Identifier: NCT01455870     History of Changes
Other Study ID Numbers: ITCA 650-CLP-105
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action