A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT01785771
First received: February 5, 2013
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

An 39-week, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks.


Condition Intervention Phase
Type 2 Diabetes
Drug: ITCA 650 (exenatide in DUROS)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c

Resource links provided by NLM:


Further study details as provided by Intarcia Therapeutics:

Primary Outcome Measures:
  • Change in HbA1c between Week 39 and Day 0 [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ITCA 650 Drug: ITCA 650 (exenatide in DUROS)

  Eligibility

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

Inclusion Criteria:

  • Men or women age 18 to 80 years with type 2 diabetes
  • On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs
  • HbA1c >10.0% and ≤12.0%

Exclusion Criteria:

  • Prior treatment with any GLP-1 receptor agonist
  • History of hypersensitivity to exenatide or liraglutide
  • FPG >300 mg/dL
  • History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
  • Taking DPP-4 inhibitors, incretin mimetics, 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: NCT01785771

Locations
United States, California
Fresno, California, United States, 93721
United States, Florida
Bradenton, Florida, United States, 34208
Miami, Florida, United States, 33183
United States, Idaho
Meridian, Idaho, United States, 83646
United States, Indiana
Franklin, Indiana, United States, 46131
Valparaiso, Indiana, United States, 46383
United States, Ohio
Columbus, Ohio, United States, 43213
Franklin, Ohio, United States, 45005
United States, South Carolina
Greer, South Carolina, United States, 29651
United States, Texas
Dallas, Texas, United States, 75251
Sponsors and Collaborators
Intarcia Therapeutics
  More Information

No publications provided

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT01785771     History of Changes
Other Study ID Numbers: ITCA 650-CLP-103-Sub-Study
Study First Received: February 5, 2013
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
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014