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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Intarcia Therapeutics
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT01455870
First received: October 18, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Drug: ITCA 650 60 mcg/day
Drug: sitagliptin
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: 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

Resource links provided by NLM:


Further study details as provided by Intarcia Therapeutics:

Primary Outcome Measures:
  • Change in HbA1c between Week 52 and Day 0 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: May 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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% - 10.5%
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455870

Contacts
Contact: Michelle Baron, MD, FACE clinicaltrials@intarcia.com

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

No publications provided

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT01455870     History of Changes
Other Study ID Numbers: ITCA 650-CLP-105
Study First Received: October 18, 2011
Last Updated: April 16, 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
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014