Back to resultsA Study to Evaluate ITCA 650 Compared to Glimepiride for the Treatment of Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ITCA 650 60 mcg/day
glimepiride
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- HbA1c between 7.5% - 10.5%
- on metformin monotherapy
- BMI between 25 & 45 kg/m2
Exclusion Criteria:
- on thiazolidinedione, sulfonylureas, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
- history of pancreatitis
Sites / Locations
- Intarcia Therapeutics, Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ITCA 650 60 mcg/day
glimepiride
Arm Description
ITCA 650 is exenatide in DUROS
glimepiride up-titrated to 8 mg/day over first 13 weeks
Outcomes
Primary Outcome Measures
Change in HbA1c
52-Week Treatment Period
Secondary Outcome Measures
Full Information
NCT ID
NCT01455883
First Posted
October 18, 2011
Last Updated
December 21, 2012
Sponsor
Intarcia Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT01455883
Brief Title
A Study to Evaluate ITCA 650 Compared to Glimepiride for the Treatment of Type 2 Diabetes
Official Title
A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intarcia Therapeutics
4. Oversight
5. Study Description
Brief Summary
Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ITCA 650 60 mcg/day
Arm Type
Experimental
Arm Description
ITCA 650 is exenatide in DUROS
Arm Title
glimepiride
Arm Type
Active Comparator
Arm Description
glimepiride up-titrated to 8 mg/day over first 13 weeks
Intervention Type
Drug
Intervention Name(s)
ITCA 650 60 mcg/day
Intervention Description
exenatide in DUROS
Intervention Type
Drug
Intervention Name(s)
glimepiride
Intervention Description
oral glimepiride does-escalated,if tolerated, to 8 mg/day
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
52-Week Treatment Period
Time Frame
52 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:
HbA1c between 7.5% - 10.5%
on metformin monotherapy
BMI between 25 & 45 kg/m2
Exclusion Criteria:
on thiazolidinedione, sulfonylureas, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
history of pancreatitis
Facility Information:
Facility Name
Intarcia Therapeutics, Inc
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate ITCA 650 Compared to Glimepiride for the Treatment of Type 2 Diabetes
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