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Amaryl M vs Metformin Uptitration in T2DM
NCT00612144Phase 4
Key facts
- Status
- Completed
- Start
- Dec 2007
- Primary completion
- May 2009
- Countries
- 1
- Sponsor
- Handok
- Modality
- Small Molecules
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 4, randomised, open-label trial of glimepiride + metformin in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Handok. Primary endpoint: Adjusted mean changes in HbA1c. Started Dec 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Amaryl M
Glimepiride/metformin fixed combination
Metformin
Metformin HCl uptitration
03
Who it enrols
Patients with Type 2 DM diagnosed for at least 3 months, treated with metformin monotherapy (500-1000mg) for at least 4 weeks, with HbA1c 7.0-10.0% and BMI 21-40 kg/m2.
04
Endpoints
Primary
Adjusted mean changes in HbA1c
Secondary
Adjusted mean changes in Fasting Plasma Glucose
Response rate based on HbA1c and FPG levels
Frequency with hypoglycemic episode
Adverse event
Abnormal change from baseline in clinical laboratory
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