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Vildagliptin vs Pioglitazone add-on to Metformin in T2DM
NCT01339143Phase 4
Key facts
- Status
- Unknown
- Start
- Apr 2010
- Primary completion
- Dec 2012
- Countries
- 1
- Sponsor
- Korea University Anam Hospital
- Modality
- Small Molecules
- Drugs
- vildagliptin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 4, randomised, open-label trial of vildagliptin in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Korea University Anam Hospital. Primary endpoint: Glycemic Variability at 16 weeks. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Vildagliptin Arm
Vildagliptin 50mg BID + Metformin
Pioglitazone Arm
Pioglitazone 15mg QD + Metformin
03
Who it enrols
Patients with Type 2 diabetes mellitus aged 18-80 years, on stable metformin (>1000mg) for at least 1 month, with HbA1c 7-10%. Excludes patients with uncontrolled hypertension (>160/100 mmHg), congestive heart failure (NYHA I-IV), or recent use of other antidiabetic agents.
04
Endpoints
Primary
Glycemic Variability
Secondary
Oxidative stress markers
Hemoglobin A1c
Hypoglycemia
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