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

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ClinicalTrials.gov Identifier: NCT00943917
Recruitment Status : Completed
First Posted : July 22, 2009
Results First Posted : May 3, 2012
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: ITCA 650 Drug: Exenatide Injection Other: Ex Inj/ITCA 650 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
Study Start Date : August 2009
Primary Completion Date : August 2010
Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ITCA 650 20 mcg/day Other: ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
Experimental: ITCA 650 40 mcg/day Other: ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
Active Comparator: Exenatide Injection 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
Experimental: ITCA 650 20/20 Other: ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
Experimental: ITCA 650 20/60 Other: ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
Experimental: ITCA 650 40/40 Other: ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
Experimental: ITCA 650 40/80 Other: ITCA 650
ITCA 650 (continuous delivery of exenatide in DUROS)
Experimental: Ex Inj/ITCA 650 40 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: Ex Inj/ITCA 650 60 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



Primary Outcome Measures :
  1. Mean Change in HbA1c (Per Protocol) [ Time Frame: Day 0 and Week 12 ]
    Mean change in HbA1c over first 12 weeks (Stage I)

  2. Mean Change in HbA1c (ITT) [ Time Frame: Day 0 to Week 12 ]
    Mean change in HbA1c through Week 12

  3. Mean Change in HbA1c (Per Protocol) [ Time Frame: Day 0 to Week 24 ]
    Mean change in HbA1c through Week 24

  4. Mean Change in HbA1c (ITT) [ Time Frame: Day 0 to Week 24 ]
    Mean change in HbA1c through Week 24

  5. Mean Change in HbA1c (Per Protocol) [ Time Frame: Day 0 to Week 48 ]
    Mean change in HbA1c through Week 48

  6. Mean Change in HbA1c (ITT) [ Time Frame: Day 0 to Week 48 ]
    Mean change in HbA1c through Week 48



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00943917


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Sponsors and Collaborators
Intarcia Therapeutics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT00943917     History of Changes
Other Study ID Numbers: ITCA 650-CLP-02
First Posted: July 22, 2009    Key Record Dates
Results First Posted: May 3, 2012
Last Update Posted: April 13, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists