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ACACIA: Anagliptin vs Sitagliptin for Glycemic Variability in Type 2 Diabetes
NCT04810507Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2018
- Primary completion
- Sep 2020
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- anagliptin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 4, randomised, double-blind trial of anagliptin in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by JW Pharmaceutical Corporation. Primary endpoint: Mean Amplitude of Glycemic Excursions at 12 weeks. Started Nov 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Anagliptin arm
Anagliptin 100 mg BID + Metformin
Sitagliptin arm
Sitagliptin 100 mg QD + Metformin
03
Who it enrols
Patients with Type 2 DM on Metformin monotherapy (>= 1000 mg) for >8 weeks with HbA1c between 6.5% and 8.5%.
04
Endpoints
Primary
Mean Amplitude of Glycemic Excursions
Secondary
Average Nighttime Blood Glucose Change
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