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ITCA 650 vs Glimepiride in Type 2 Diabetes
NCT01455922Phase 3
Key facts
- Status
- Withdrawn
- Start
- Feb 2013
- Primary completion
- Jul 2014
- Countries
- 1
- Sponsor
- Intarcia Therapeutics
- Modality
- Peptides, Device-based Delivery
- Drugs
- ITCA 650
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial of ITCA 650 in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Intarcia Therapeutics. Primary endpoint: Change in HbA1c at 52 weeks. Planned start Feb 2013; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
ITCA 650
ITCA 650 60 mcg/day + Metformin
Glimepiride
Glimepiride (titrated to 8 mg/day) + Metformin
03
Who it enrols
Patients with Type 2 Diabetes on metformin monotherapy with HbA1c between 7.5% and 10.5% and BMI between 25 and 45 kg/m2.
04
Endpoints
Primary
Change in HbA1c
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