J Korean Diabetes Assoc.  2006 Nov;30(6):466-475.

Comparison of the Efficacy and Safety of Glimepiride/Metformin Fixed Combination Versus Free Combination in Patients with Type 2 Diabetes: Multicenter, Randomized, Controlled Trial

• Lee SH
• Lee IK
• Baik SH
• Choi DS
• Park KS
• Song KH
• Lee KW
• Cha BS
• Ahn CW
• Lee HW
• Chung CH
• Nam MS
• Baek HS
• Kim YK
• Rhim HY
• Son HY

Abstract

BACKGROUND: Failure to manage diabetes mellitus receiving monotherapy increases as the duration of the disease is protracted, and in many cases it becomes inevitable to introduce combined therapies. However, compliance of the patients tends to decrease. We conducted a clinical study to compare the efficacy and safety of preconstituted and fixed combination therapy of glimepiride plus metformin to those of free combination therapy.
METHODS
Two hundred and thirteen patients with type 2 diabetes who had been diagnosed at least six months ago were randomly assigned either to a fixed group or a free group. The initial dosage was chosen according to the previous treatment history and then adjusted every two weeks following a predefined titration algorithm to meet the target mean fasting glucose levels (140 mg/dL). The medications were given for 16 weeks. The primary endpoint was the change in HbA1c level from baseline to week 16. Various parameters were checked as secondary outcome measures and safety criteria.
RESULTS
HbA1c level of the fixed group and the free group decreased by 1.09% and 1.08%, respectively. The 95% CI of the changes' difference between the two groups (-0.21%, +0.19%) was within the predefined equivalence interval (-0.5%, +0.5%). Secondary outcome measures (the changes of fasting and postprandial plasma glucose level, response rate and compliance) and safety criteria (frequency of hypoglycemia and adverse reactions) were similar between the two groups.
CONCLUSION
Fixed combination of glimepiride/metformin is as effective and safe therapy as free combination in type 2 diabetes patients.

Keyword

Combination; Glimepiride; Metformin; Type 2 diabetes

MeSH Terms

Blood Glucose
Compliance
Diabetes Mellitus
Fasting
Glucose
Humans
Hypoglycemia
Metformin
Outcome Assessment (Health Care)
Glucose
Metformin

Figure

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  Fig. 1 Flow of patients through the study. ITT, intent-to-treat; PP, per protocol.

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