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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
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes
 Other: ITCA 650
Drug: Exenatide Injection
Other: Ex Inj/ITCA 650
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

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

Further study details as provided by Intarcia Therapeutics:

Primary Outcome Measures:
  • 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


Enrollment: 155
Study Start Date: August 2009
Study Completion Date: February 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943917

  Show 50 Study Locations
Sponsors and Collaborators
Intarcia Therapeutics
  More Information

No publications provided

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT00943917     History of Changes
Other Study ID Numbers: ITCA 650-CLP-02
Study First Received: July 20, 2009
Results First Received: February 24, 2012
Last Updated: November 13, 2012
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
 Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013