Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

Overview

The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.

Full Title of Study: “Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2010

Interventions

  • Other: ITCA 650
    • ITCA 650 (continuous delivery of exenatide in DUROS)
  • Drug: Exenatide Injection
    • twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks
  • Other: Ex Inj/ITCA 650
    • twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650

Arms, Groups and Cohorts

  • Experimental: ITCA 650 20 mcg/day
  • Experimental: ITCA 650 40 mcg/day
  • Active Comparator: Exenatide Injection
  • Experimental: ITCA 650 20/20
  • Experimental: ITCA 650 20/60
  • Experimental: ITCA 650 40/40
  • Experimental: ITCA 650 40/80
  • Experimental: Ex Inj/ITCA 650 40
  • Experimental: Ex Inj/ITCA 650 60

Clinical Trial Outcome Measures

Primary Measures

  • Mean Change in HbA1c (Per Protocol)
    • Time Frame: Day 0 and Week 12
    • Mean change in HbA1c over first 12 weeks (Stage I)
  • Mean Change in HbA1c (ITT)
    • Time Frame: Day 0 to Week 12
    • Mean change in HbA1c through Week 12
  • Mean Change in HbA1c (Per Protocol)
    • Time Frame: Day 0 to Week 24
    • Mean change in HbA1c through Week 24
  • Mean Change in HbA1c (ITT)
    • Time Frame: Day 0 to Week 24
    • Mean change in HbA1c through Week 24
  • Mean Change in HbA1c (Per Protocol)
    • Time Frame: Day 0 to Week 48
    • Mean change in HbA1c through Week 48
  • Mean Change in HbA1c (ITT)
    • Time Frame: Day 0 to Week 48
    • Mean change in HbA1c through Week 48

Participating in This Clinical Trial

Inclusion Criteria

  • Males or females age 18-70 years – Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1 – On a stable (> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy; – Fasting plasma glucose < 240 mg/dL at Screening Visit 1 – HbA1c ≥ 7% and ≤ 10% at Screening Visit 1 Exclusion Criteria:

  • Prior treatment with exenatide – Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled) – History of type 1 diabetes and/or history of diabetic ketoacidosis – Body mass index ≥ 40 kg/m2; – History of organ transplantation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.