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

Overview

Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.

Full Title of Study: “A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2014

Interventions

  • Drug: ITCA 650 60 mcg/day
    • exenatide in DUROS
  • Drug: sitagliptin
    • sitagliptin oral 100 mg/day

Arms, Groups and Cohorts

  • Experimental: ITCA 650 60 mcg/day
  • Active Comparator: sitagliptin
    • sitagliptin 100 mg/day

Clinical Trial Outcome Measures

Primary Measures

  • Change in HbA1c
    • Time Frame: 39 weeks
    • 39-week treatment period followed by 65-week extension period

Participating in This Clinical Trial

Inclusion Criteria

  • HbA1c between 7.5%-10% – on metformin monotherapy – BMI between 25 & 45 kg/m2 Exclusion Criteria:

  • taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months – history of pancreatitis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Intarcia Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor

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