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

This study is currently recruiting participants.
Verified April 2013 by Intarcia Therapeutics
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT01455857
First received: October 18, 2011
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes
 Drug: ITCA 650
Other: ITCA placebo
 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: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Intarcia Therapeutics:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: 39 weeks ] [ Designated as safety issue: No ]
    39-week Treatment Period


Estimated Enrollment: 450
Study Start Date: March 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 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)

  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%
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455857

Contacts
Contact: Michelle Baron, MD, FACE clinicaltrials@intarcia.com

  Show 133 Study Locations
Sponsors and Collaborators
Intarcia Therapeutics
  More Information

No publications provided

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT01455857     History of Changes
Other Study ID Numbers: ITCA 650-CLP-103
Study First Received: October 18, 2011
Last Updated: April 15, 2013
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

ClinicalTrials.gov processed this record on May 16, 2013