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

March 23, 2015 updated by: Intarcia Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • 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
        • Study Site
    • Colorado
      • Longmont, Colorado, United States, 80501
        • Study Site
      • Pueblo, Colorado, United States, 81001
        • Study Site
    • Florida
      • Bradenton, Florida, United States, 34203
        • Study Site
      • Miami, Florida, United States, 33143
        • Study Site
      • Miami, Florida, United States, 33169
        • Study Site
      • Miami, Florida, United States, 33183
        • Study Site
      • Miramar, Florida, United States, 33025
        • Study Site
      • Pembroke Pines, Florida, United States, 33026
        • Study Site
      • St Petersburg, Florida, United States, 33709
        • Study Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Study Site
      • Sandy Springs, Georgia, United States, 30328
        • Study Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Study Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Study Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Study Site
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Study Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Study Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Study Site
    • Michigan
      • 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
        • Study Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Study Site
    • New York
      • New Hyde Park, New York, United States, 11042
        • Study Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Study Site
      • Hickory, North Carolina, United States, 28601
        • Study Site
    • Ohio
      • 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
        • Study Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Study Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Study Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Study Site
    • Texas
      • Austin, Texas, United States, 78749
        • Study Site
      • Austin, Texas, United States, 78752
        • Study Site
      • Dallas, Texas, United States, 75230
        • Study Site
      • Dallas, Texas, United States, 75251
        • Study Site
      • Irving, Texas, United States, 75039
        • Study Site
      • San Antonio, Texas, United States, 78205
        • Study Site
      • San Antonio, Texas, United States, 78229
        • Study Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Study Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Study Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Study Site
      • Spokane, Washington, United States, 99202
        • Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Byetta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in HbA1c (Per Protocol)
Time Frame: Day 0 and Week 12
Mean change in HbA1c over first 12 weeks (Stage I)
Day 0 and Week 12
Mean Change in HbA1c (ITT)
Time Frame: Day 0 to Week 12
Mean change in HbA1c through Week 12
Day 0 to Week 12
Mean Change in HbA1c (Per Protocol)
Time Frame: Day 0 to Week 24
Mean change in HbA1c through Week 24
Day 0 to Week 24
Mean Change in HbA1c (ITT)
Time Frame: Day 0 to Week 24
Mean change in HbA1c through Week 24
Day 0 to Week 24
Mean Change in HbA1c (Per Protocol)
Time Frame: Day 0 to Week 48
Mean change in HbA1c through Week 48
Day 0 to Week 48
Mean Change in HbA1c (ITT)
Time Frame: Day 0 to Week 48
Mean change in HbA1c through Week 48
Day 0 to Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intarcia Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

July 20, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (Estimate)

July 22, 2009

Study Record Updates

Last Update Posted (Estimate)

April 13, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITCA 650-CLP-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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