Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy 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:
NCT01455870
First received: October 18, 2011
Last updated: September 30, 2014
Last verified: September 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: July 2015
Estimated Primary Completion Date: June 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

  Hide Study Locations
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, 60634
Chicago, Illinois, United States, 60607
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, 67208
Wichita, Kansas, United States, 67205
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, 75390
Dallas, Texas, United States, 75230
Houston, Texas, United States, 77083
San Antonio, Texas, United States, 78229
Sugar Land, Texas, United States, 77478
Tomball, Texas, United States, 77375
Croatia
Rijeka, Croatia, 51000
Denmark
Hvidovre, Denmark, 2650
Germany
Bad Lauterberg im Harz, Niedersachsen, Germany, 37431
Latvia
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: September 30, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014