A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2013
Shorter than P25 for phase_3 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedDecember 25, 2012
December 1, 2012
1.4 years
October 18, 2011
December 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c
52-week Treatment Period followed by 52-week Extension Period
52 weeks
Study Arms (2)
ITCA 650 60 mcg/day
EXPERIMENTALglimepiride
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- HbA1c between 7.5% - 10.5%
- on metformin monotherapy
- BMI between 25 \& 45 kg/m2
You may not qualify if:
- On thiazolidinedione, sulfonylurea, DPP-4, alpha glucosidase inhibitor, meglitinides or insulin within last 3 months
- history of pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Intarcia Therapeutics, Inc
Hayward, California, 94545, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2011
First Posted
October 20, 2011
Study Start
February 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
December 25, 2012
Record last verified: 2012-12