Efficacy and safety of rosiglitazone plus metformin in Mexicans with type 2 diabetes.
BACKGROUND
Type 2 diabetes is a growing problem in Mexico. The present study was undertaken to evaluate the efficacy and safety of rosiglitazone 2 mg or 4 mg twice daily (bd) in combination with metformin 2.5 g/day in Mexican patients whose type 2 diabetes was inadequately controlled with metformin alone.


METHODS
This randomized, double-blind, placebo-controlled study was conducted at four centers in Mexico. A total of 116 patients were randomized to metformin 2.5 g/day plus placebo (n=39), metformin 2.5 g/day plus rosiglitazone 2 mg bd (n=37), or metformin 2.5 g/day plus rosiglitazone 4 mg bd (n=40) for 26 weeks.


RESULTS
Mean hemoglobin A(1c) (HbA(1c)) levels decreased significantly from baseline to Week 26 in the rosiglitazone 2 mg bd (-0.7%; p=0.0052) and 4 mg bd (-1.2%; p=0.0008) groups, but increased in the placebo group (+0.3%; p=0.2651). Mean fasting plasma glucose and fructosamine levels also improved significantly with metformin plus rosiglitazone therapy in a dose-ordered manner compared with placebo (p<or=0.0019 and p=0.0006, respectively). C-peptide and immunoreactive insulin levels were decreased from baseline in both rosiglitazone groups. Although mean increases in total cholesterol, low-density lipoprotein (LDL)-cholesterol, and high-density lipoprotein (HDL)-cholesterol were observed in the rosiglitazone groups, the total cholesterol:HDL-cholesterol ratio remained unchanged. The proportion of patients with one or more adverse events was similar across all three groups. There were no cases of hepatotoxicity.


CONCLUSIONS
Addition of rosiglitazone 2 mg bd and 4 mg bd to metformin therapy improved glycemic control in Mexican patients whose type 2 diabetes was inadequately controlled by metformin alone. Furthermore, the combination of rosiglitazone plus metformin was well tolerated.
Gómez-Perez
Francisco J
FJ
Instituto Nacional de Ciencias Medicas y Nutricion S.Z., Mexico City, Mexico.
Fanghänel-Salmón
Guillermo
G
Antonio Barbosa
Juan
J
Montes-Villarreal
Juan
J
Berry
Rhona A
RA
Warsi
Ghulam
G
Gould
Errol M
EM
D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005006:Ethnicity; D005230:Fatty Acids, Nonesterified / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008075:Lipoproteins, HDL / Q000097:blood; D008077:Lipoproteins, LDL / Q000097:blood; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008800:Mexico; D008875:Middle Aged; D010919:Placebos; D000077154:Rosiglitazone; D012449:Safety; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D045162:Thiazolidinediones; D014280:Triglycerides / Q000097:blood
D001786:Blood Glucose; D005230:Fatty Acids, Nonesterified; D006442:Glycated Hemoglobin; D008075:Lipoproteins, HDL; D008077:Lipoproteins, LDL; D008687:Metformin; D010919:Placebos; D000077154:Rosiglitazone; D013844:Thiazoles; D045162:Thiazolidinediones; D014280:Triglycerides