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

  Hide Study Locations
Locations
United States, California
Study Site
Chino, California, United States, 91710
Study Site
La Jolla, California, United States, 92037
Study Site
National City, California, United States, 91950
Study Site
Sacramento, California, United States, 95821
Study Site
San Diego, California, United States, 92161
Study Site
Valley Village, California, United States, 91607
United States, Colorado
Study Site
Longmont, Colorado, United States, 80501
Study Site
Pueblo, Colorado, United States, 81001
United States, Florida
Study Site
Bradenton, Florida, United States, 34203
Study Site
Miami, Florida, United States, 33169
Study Site
Miami, Florida, United States, 33183
Study Site
Miami, Florida, United States, 33143
Study Site
Miramar, Florida, United States, 33025
Study Site
Pembroke Pines, Florida, United States, 33026
Study Site
St Petersburg, Florida, United States, 33709
United States, Georgia
Study Site
Atlanta, Georgia, United States, 30342
Study Site
Sandy Springs, Georgia, United States, 30328
United States, Idaho
Study Site
Meridian, Idaho, United States, 83642
United States, Illinois
Study Site
Chicago, Illinois, United States, 60607
United States, Indiana
Study Site
Avon, Indiana, United States, 46123
United States, Kansas
Study Site
Wichita, Kansas, United States, 67205
United States, Kentucky
Study Site
Lexington, Kentucky, United States, 40503
United States, Louisiana
Study Site
New Orleans, Louisiana, United States, 70112
United States, Michigan
Study Site
Kalamazoo, Michigan, United States, 49007
Study Site
Traverse City, Michigan, United States, 49684
Study Site
Troy, Michigan, United States, 48098
Study Site
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Study Site
Minneapolis, Minnesota, United States, 55416
United States, Nevada
Study Site
Las Vegas, Nevada, United States, 89119
United States, New York
Study Site
New Hyde Park, New York, United States, 11042
United States, North Carolina
Study Site
Charlotte, North Carolina, United States, 28209
Study Site
Hickory, North Carolina, United States, 28601
United States, Ohio
Study Site
Cincinatti, Ohio, United States, 45212
Study Site
Cincinnati, Ohio, United States, 45219
Study Site
Franklin, Ohio, United States, 45005
Study Site
Kettering, Ohio, United States, 45429
United States, Oklahoma
Study Site
Norman, Oklahoma, United States, 73069
United States, Oregon
Study Site
Eugene, Oregon, United States, 97404
United States, South Dakota
Study Site
Rapid City, South Dakota, United States, 57702
United States, Texas
Study Site
Austin, Texas, United States, 78752
Study Site
Austin, Texas, United States, 78749
Study Site
Dallas, Texas, United States, 75251
Study Site
Dallas, Texas, United States, 75230
Study Site
Irving, Texas, United States, 75039
Study Site
San Antonio, Texas, United States, 78229
Study Site
San Antonio, Texas, United States, 78205
United States, Utah
Study Site
West Jordan, Utah, United States, 84088
United States, Virginia
Study Site
Norfolk, Virginia, United States, 23502
United States, Washington
Study Site
Olympia, Washington, United States, 98502
Study Site
Spokane, Washington, United States, 99202
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 September 18, 2014