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Basalin to Lantus Switch in T2DM
NCT03631121Phase 4
Key facts
- Status
- Unknown
- Start
- Aug 2018
- Primary completion
- Dec 2018
- Countries
- 1
- Sponsor
- Nanjing First Hospital
- Modality
- Small Molecules
- Drugs
- fluralaner
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 4, open-label, single-arm trial of fluralaner in type 2 diabetes mellitus (T2DM), sponsored by Nanjing First Hospital. Primary endpoint: Change of glycemic variation. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Basalin to Lantus
Patients switch from Basalin to Lantus.
03
Who it enrols
Patients with T2DM using Basalin for >3 months with stable dose and constant diet/exercise, having fasting blood glucose <6.1mmol/L and postprandial <14mmol/L. Excludes severe cardiovascular diseases, severe infectious diseases, acute complications, and psychiatric disorders.
04
Endpoints
Primary
Change of glycemic variation
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