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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Intarcia Therapeutics

Additional 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
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 21, 2014