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

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.
 
ClinicalTrials.gov Identifier: NCT01455857
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics

Study Description
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Brief Summary:
Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: ITCA 650 Other: ITCA placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes
Study Start Date : March 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: ITCA 650 40 mcg/day Drug: ITCA 650
ITCA 650 is exenatide in DUROS
Experimental: ITCA 650 60 mcg/day Drug: ITCA 650
ITCA 650 is exenatide in DUROS
Placebo Comparator: ITCA placebo Other: ITCA placebo
Formulation in DUROS (no exenatide)


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 39 weeks ]
    39-week Treatment Period


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • HbA1c between 7.5% - 10%
  • On diet & exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU
  • BMI between 25 & 45 kg/m2

Exclusion Criteria:

  • taking DPP-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
  • history of pancreatitis
Contacts and Locations
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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): NCT01455857


Locations
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Sponsors and Collaborators
Intarcia Therapeutics
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT01455857    
Other Study ID Numbers: ITCA 650-CLP-103
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Glucagon-Like Peptide-1 Receptor Agonists
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists