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A Study to Evaluate ITCA 650 Compared to Glimepiride for the Treatment of Type 2 Diabetes

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01455883
First Posted: October 20, 2011
Last Update Posted: December 25, 2012
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.
Information provided by (Responsible Party):
Intarcia Therapeutics
  Purpose
Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.

Condition Intervention Phase
Type 2 Diabetes Drug: ITCA 650 60 mcg/day Drug: glimepiride Phase 3

Study Type: Interventional
Study Design: 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 Glimepiride 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 [ Time Frame: 52 weeks ]
    52-Week Treatment Period


Enrollment: 0
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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: glimepiride
glimepiride up-titrated to 8 mg/day over first 13 weeks
Drug: glimepiride
oral glimepiride does-escalated,if tolerated, to 8 mg/day

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • HbA1c between 7.5% - 10.5%
  • on metformin monotherapy
  • BMI between 25 & 45 kg/m2

Exclusion Criteria:

  • on thiazolidinedione, sulfonylureas, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
  • history of pancreatitis
  Contacts and Locations
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): NCT01455883


Locations
United States, California
Intarcia Therapeutics, Inc
Hayward, California, United States, 94545
Sponsors and Collaborators
Intarcia Therapeutics
  More Information

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT01455883     History of Changes
Other Study ID Numbers: ITCA 650-CLP-106
First Submitted: October 18, 2011
First Posted: October 20, 2011
Last Update Posted: December 25, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Exenatide
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists