Efficacy of glimepiride/metformin combination versus glibenclamide/metformin in patients with uncontrolled type 2 diabetes mellitus.
OBJECTIVE
The aim of this study was to compare the efficacy of glimepiride/metformin combination versus glibenclamide/metformin for reaching glycemic control in patients with uncontrolled type 2 diabetes mellitus.


METHODS
A randomized, double-blind, multicenter clinical trial was performed in 152 uncontrolled type 2 diabetic patients. Serum fasting and postprandial glucose, hemoglobin A1c (A1C), high-density lipoprotein cholesterol, and triglycerides were measured. After random allocation, all patients received two pills of glimepiride (1 mg)/metformin (500 mg) or glibenclamide (5 mg)/metformin (500 mg) po once a day. Dosage was increased to a maximum of four pills in order to reach the glycemic control goals (fasting glucose <or=7.2 mmol/l, postprandial glucose <10.0 mmol/l, A1C <7%, or an A1C >or=1% reduction). Statistical analyses were carried out using chi-square, ANOVA, or Student's t test. The protocol was approved by an ethics committee and met all requirements needed to perform research in human subjects; all patients gave written informed consent.


RESULTS
Each study group included 76 patients. No significant differences in basal clinical and laboratory characteristics between groups were found. At the end of the study, A1C concentration was significantly lower in the glimepiride/metformin group (P=.025). A higher proportion of patients from the glimepiride group (44.6% vs. 26.8%, P<.05) reached the goal of A1C <7% at 12 months of treatment. A higher proportion of hypoglycemic events were observed in the glibenclamide group (28.9% vs. 17.1%, P<.047).


CONCLUSIONS
Glimepiride/metformin demonstrated being more efficacious than glibenclamide/metformin at reaching the glycemic control goals with less hypoglycemic events in patients with uncontrolled type 2 diabetes mellitus.
González-Ortiz
Manuel
M
Medical Research Unit in Clinical Epidemiology, Specialties Hospital, Medical Unit of High Specialty, West National Medical Center, Mexican Institute of Social Security, Guadalajara, Mexico. uiec@prodigy.net.mx
Guerrero-Romero
Jesús F
JF
Violante-Ortiz
Rafael
R
Wacher-Rodarte
Niels
N
Martínez-Abundis
Esperanza
E
Aguilar-Salinas
Carlos
C
Islas-Andrade
Sergio
S
Arechavaleta-Granell
Rosario
R
González-Canudas
Jorge
J
Rodríguez-Morán
Martha
M
Zavala-Suárez
Etelvina
E
Ramos-Zavala
Maria G
MG
Metha
Roopa
R
Revilla-Monsalve
Cristina
C
Beltrán-Jaramillo
Teresita J
TJ
D001786:Blood Glucose / Q000187:drug effects; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004338:Drug Combinations; D005260:Female; D005905:Glyburide / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D006943:Hyperglycemia / Q000188:drug therapy; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008687:Metformin / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D013453:Sulfonylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D001786:Blood Glucose; D004338:Drug Combinations; D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; C057619:glimepiride; D008687:Metformin; D005905:Glyburide