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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT00943917
First received: July 20, 2009
Last updated: November 13, 2012
Last verified: November 2012

July 20, 2009
November 13, 2012
August 2009
August 2010   (final data collection date for primary outcome measure)
  • Mean Change in HbA1c (Per Protocol) [ Time Frame: Day 0 and Week 12 ] [ Designated as safety issue: No ]
    Mean change in HbA1c over first 12 weeks (Stage I)
  • Mean Change in HbA1c (ITT) [ Time Frame: Day 0 to Week 12 ] [ Designated as safety issue: No ]
    Mean change in HbA1c through Week 12
  • Mean Change in HbA1c (Per Protocol) [ Time Frame: Day 0 to Week 24 ] [ Designated as safety issue: No ]
    Mean change in HbA1c through Week 24
  • Mean Change in HbA1c (ITT) [ Time Frame: Day 0 to Week 24 ] [ Designated as safety issue: No ]
    Mean change in HbA1c through Week 24
  • Mean Change in HbA1c (Per Protocol) [ Time Frame: Day 0 to Week 48 ] [ Designated as safety issue: No ]
    Mean change in HbA1c through Week 48
  • Mean Change in HbA1c (ITT) [ Time Frame: Day 0 to Week 48 ] [ Designated as safety issue: No ]
    Mean change in HbA1c through Week 48
Not Provided
Complete list of historical versions of study NCT00943917 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus
Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • 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 Name: Byetta
  • 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
    Other Name: Byetta
  • Experimental: ITCA 650 20 mcg/day
    Intervention: Other: ITCA 650
  • Experimental: ITCA 650 40 mcg/day
    Intervention: Other: ITCA 650
  • Active Comparator: Exenatide Injection
    Intervention: Drug: Exenatide Injection
  • Experimental: ITCA 650 20/20
    Intervention: Other: ITCA 650
  • Experimental: ITCA 650 20/60
    Intervention: Other: ITCA 650
  • Experimental: ITCA 650 40/40
    Intervention: Other: ITCA 650
  • Experimental: ITCA 650 40/80
    Intervention: Other: ITCA 650
  • Experimental: Ex Inj/ITCA 650 40
    Intervention: Other: Ex Inj/ITCA 650
  • Experimental: Ex Inj/ITCA 650 60
    Intervention: Other: Ex Inj/ITCA 650
Henry RR, Rosenstock J, Logan DK, Alessi TR, Luskey K, Baron MA. Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes. Diabetes Care. 2013 Sep;36(9):2559-65. doi: 10.2337/dc12-2410. Epub 2013 May 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
155
February 2011
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00943917
ITCA 650-CLP-02
No
Intarcia Therapeutics
Intarcia Therapeutics
Not Provided
Not Provided
Intarcia Therapeutics
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP