NCT00612144

Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM

A Multicenter, Randomized, Parallel-group, Open Study to Compare the Efficacy and Safety of Early Combination Therapy With Amaryl M to Metformin Uptitration in Type 2 DM Patients Inadequately Controlled on Metformin HCL

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Handok Inc. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately controlled by prior monotherapy with metformin.

Detailed description

Treatment algorithms for type 2 DM generally employ monotherapy as a first-line pharmacologic treatment option. Disease progression renders monotherapy less effective in controlling blood glucose over time, with approximately half of the patients requiring additional therapy by 3 years after diagnosis. As a result, the use of multiple pharmacologic agents to control blood glucose is well accepted. In combination therapy, selection of suitable drug may be individualized depending on their health conditions. However, it is advisable to select drugs having different mechanism considering their complimentary action with each other. Therefore, sulfonylureas and metformin HCL is the best combination in which "insulin deficiency" and "insulin resistance", the basic two pathophysiologies in type 2 diabetes could be targeted. The efficacy and safety of the combination with sulfonylureas and metformin HCL have been proven in numerous clinical studies as combination is more effective than monotherapy using each drug in blood glucose control. Also, new approaches are required in order to attain and maintain good glycaemic control over time and aggressive earlier introduction of combination therapy is being increasingly recommended over conventional stepwise strategies.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Glimepiride/metformin fixed combination	Amaryl M 1/250mg\~4/1000mg bid for 12\~26 weeks * Maintenance dose for 10 weeks after 2\~14 weeks of dose titration * Dose titration according to titration algorithm based on daily mean SMBG
DRUG	Metformin HCl	Metformin HCl 500mg\~1250mg bid for 12\~26 weeks * Maintenance dose for 10 weeks after 2\~14 weeks of dose titration * Dose titration according to titration algorithm based on daily mean SMBG

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-02-11
• Last updated: 2013-03-28

Locations

1 site across 1 country: South Korea