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

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ClinicalTrials.gov Identifier: NCT01785771
Recruitment Status : Terminated (Decision by Sponsor)
First Posted : February 7, 2013
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics

Brief Summary:
An 39-week plus extensions, 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 plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2013
Primary Completion Date : January 2018
Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ITCA 650 Drug: ITCA 650 (exenatide in DUROS)



Primary Outcome Measures :
  1. Change in HbA1c between Week 39 and Day 0 [ Time Frame: 39 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
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

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 ClinicalTrials.gov identifier (NCT number): NCT01785771


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Sponsors and Collaborators
Intarcia Therapeutics

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT01785771     History of Changes
Other Study ID Numbers: ITCA 650-CLP-103-Sub-Study
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists