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A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c

Primary Purpose

Type 2 Diabetes

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ITCA 650 (exenatide in DUROS)
Sponsored by
Intarcia Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women age 18 to 80 years with type 2 diabetes
  • On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs
  • HbA1c >10.0% and ≤12.0%

Exclusion Criteria:

  • Prior treatment with any GLP-1 receptor agonist
  • History of hypersensitivity to exenatide or liraglutide
  • FPG >300 mg/dL
  • History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
  • Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
  • history of pancreatitis

Sites / Locations

  • Alabama Clinical Therapeutics, LLC
  • Fundamental Research
  • East Valley Family Physicians, PLC
  • Desert Clinical Research
  • Clinical Research Advantage, Inc.
  • eStudySite
  • Rocks Medical Research Institute, Inc.
  • Rocks Medical Research Institute
  • Long Beach Center for Clinical Research
  • Saviers Medical Group
  • University Clinical Investigatons, Inc/Diabetes Research Center
  • Diablo Clinical Research, Inc.
  • Colorado Springs Health Partners-Briargate
  • Meridien Research
  • East Coast Institute for Research, LLC
  • New Horizon Research Center, Inc.
  • International Research Assocaites, LLC
  • Harmony Clinical Research, Inc.
  • Palm Harbor Medical Associates
  • Andres Patron, D.O., P.A.
  • Clinical Research of West Florida
  • Perimeter Institute for Clinical Research PRIME
  • Solaris Clinical Research
  • Chicago Research Center
  • American Health Network of Indiana, LLC
  • Medisphere Medical Research Center, LLC
  • American Health Network of Indiana
  • American Health Network of Indiana, LLC
  • Bunyan Clinical Research
  • Crescent City Clinical Research Center
  • Palm Research Center, Inc.
  • PMG Research of Charlotte, LLC
  • University of North Carolina at Chapel Hill
  • PMG Research of Salisbury, LLC
  • PMG Research of Winston-Salem, LLC
  • Sentral Clinical Research Services, LLC
  • Columbus Clinical Research
  • Prestige Clinical Research
  • Lynn Institute of Norman
  • Preferred Primary Care Physicians
  • BMG The Endocrine Clinic
  • Tekton Research, Inc.
  • 3rd Coast Research Associates
  • Dallas Diabetes and Endocrine Center
  • Galena Research
  • University of Texas Southwestern Medical Center
  • Medstar Clinical Research and Associates
  • Clinical Trials of Texas, Inc.
  • Sound Healthcare
  • Ranier Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ITCA 650

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c between Week 39 and Day 0

Secondary Outcome Measures

Full Information

First Posted
February 5, 2013
Last Updated
March 4, 2019
Sponsor
Intarcia Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01785771
Brief Title
A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c
Official Title
An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Decision by Sponsor
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intarcia Therapeutics

4. Oversight

5. Study Description

Brief Summary
An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c >10% </=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ITCA 650
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ITCA 650 (exenatide in DUROS)
Primary Outcome Measure Information:
Title
Change in HbA1c between Week 39 and Day 0
Time Frame
39 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women age 18 to 80 years with type 2 diabetes On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs HbA1c >10.0% and ≤12.0% Exclusion Criteria: Prior treatment with any GLP-1 receptor agonist History of hypersensitivity to exenatide or liraglutide FPG >300 mg/dL History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2 Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months history of pancreatitis
Facility Information:
Facility Name
Alabama Clinical Therapeutics, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Fundamental Research
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
Country
United States
Facility Name
East Valley Family Physicians, PLC
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Desert Clinical Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
eStudySite
City
Chula Vista
State/Province
California
Country
United States
Facility Name
Rocks Medical Research Institute, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Rocks Medical Research Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Long Beach Center for Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Saviers Medical Group
City
Port Hueneme
State/Province
California
ZIP/Postal Code
93041
Country
United States
Facility Name
University Clinical Investigatons, Inc/Diabetes Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Colorado Springs Health Partners-Briargate
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80922
Country
United States
Facility Name
Meridien Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
New Horizon Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
International Research Assocaites, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Harmony Clinical Research, Inc.
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Palm Harbor Medical Associates
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Andres Patron, D.O., P.A.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Perimeter Institute for Clinical Research PRIME
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Chicago Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
American Health Network of Indiana, LLC
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Medisphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
American Health Network of Indiana
City
Franklin
State/Province
Indiana
ZIP/Postal Code
46131
Country
United States
Facility Name
American Health Network of Indiana, LLC
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Bunyan Clinical Research
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Crescent City Clinical Research Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Palm Research Center, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
PMG Research of Charlotte, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
PMG Research of Salisbury, LLC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sentral Clinical Research Services, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Columbus Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Preferred Primary Care Physicians
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
BMG The Endocrine Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Tekton Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
3rd Coast Research Associates
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Dallas Diabetes and Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Galena Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Medstar Clinical Research and Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77083
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Angelo
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sound Healthcare
City
Port Orchard
State/Province
Washington
ZIP/Postal Code
98366
Country
United States
Facility Name
Ranier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29301824
Citation
Henry RR, Rosenstock J, Denham DS, Prabhakar P, Kjems L, Baron MA. Clinical Impact of ITCA 650, a Novel Drug-Device GLP-1 Receptor Agonist, in Uncontrolled Type 2 Diabetes and Very High Baseline HbA1c: The FREEDOM-1 HBL (High Baseline) Study. Diabetes Care. 2018 Mar;41(3):613-619. doi: 10.2337/dc17-1519. Epub 2018 Jan 4.
Results Reference
derived

Learn more about this trial

A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c

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