17557
document
Effects of pioglitazone and glimepiride on glycemic control and insulin sensitivity in Mexican patients with type 2 diabetes mellitus : A multicenter , randomized , double-blind , parallel-group trial . BACKGROUND Pioglitazone and glimepiride improve glycemic control in patients with type 2 diabetes mellitus by different mechanisms . Pioglitazone is a thiazolidinedione that reduces insulin resistance , and glimepiride is a sulfonylurea insulin secretagogue . OBJECTIVE The goals of this study were to compare changes in measures of glycemic control and insulin sensitivity in Mexican patients with type 2 diabetes who received pioglitazone or glimepiride for 1 year . METHODS This was a multicenter , 52-week , double-blind , parallel-group trial . Patients were randomized to receive monotherapy with either glimepiride ( 2 mg QD initially ) or pioglitazone ( 15 mg QD initially ) . Doses were titrated ( maximal doses : pioglitazone 45 mg , glimepiride 8 mg ) to achieve glycemic targets ( fasting blood glucose < or =7 mmol/L and 1-hour postprandial blood glucose < or =10 mmol/L ) . Insulin sensitivity ( primary end point ) was evaluated in terms of the Homeostasis Model Assessment for Insulin Sensitivity ( HOMA-S ) , the Quantitative Insulin Sensitivity Check Index ( QUICKI ) , and fasting serum insulin ( FSI ) concentrations . Glycemic control was evaluated in terms of glycosylated hemoglobin ( HbA ( 1c ) ) values and fasting plasma glucose ( FPG ) concentrations . Patients were encouraged to maintain their individual diet and exercise regimens throughout the study . RESULTS Two hundred forty-four patients ( 125 women , 119 men ; all but 1 Hispanic ) were randomized to receive pioglitazone ( n = 121 ) or glimepiride ( n = 123 ) . In the intent-to-treat sample , pioglitazone and glimepirede produced comparable reductions in HbA ( 1c ) from baseline to the end of the study ( -0.78 % and -0.68 % , respectively ) . The pioglitazone group had significantly higher HbA ( 1c ) values compared with the glimepiride group after 12 weeks of therapy ( 8.66 % vs 7.80 % ; P = 0.007 ) but had significantly lower values after 52 weeks ( 7.46 % vs 7.77 % ; P = 0.027 ) . Pioglitazone significantly reduced FPG compared with glimepiride ( -0.6 vs 0.6 mmol/L ; P = 0.01 ) . Pioglitazone therapy was associated with significant increases in insulin sensitivity ( reduced insulin resistance ) , whereas glimepiride had no effect . HOMA-S values changed 18.0 % for pioglitazone and -7.9 % for glimepiride ( P < 0.001 ) , QUICKI values changed a respective 0.013 and -0.007 ( P < 0.001 ) , and FSI values were -21.1 and 15.1 pmol/L ( P < 0.001 ) . Both drugs were well tolerated , with pioglitazone associated with more peripheral edema ( number of treatment-emergent cases : 35/121 [ 28.9 % ] vs 17/123 [ 13.8 % ] ; P = 0.005 ) and fewer hypoglycemic episodes ( 19 [ 15.7 % ] vs 38 [ 30.9 % ] ; P = 0.024 ) . The incidence of weight gain was not significantly different between treatment groups . CONCLUSIONS These data suggest that long-term treatment with pioglitazone enhances insulin sensitivity relative to glimepiride in Mexican patients with type 2 diabetes and that pioglitazone may have a more sustained antihyperglycemic effect .
17558
Intervention_Pharmacological
pioglitazone
17559
Intervention_Pharmacological
glimepiride
17560
Intervention_Pharmacological
Pioglitazone
17561
Intervention_Pharmacological
glimepiride
17562
Intervention_Pharmacological
Pioglitazone
17563
Intervention_Pharmacological
glimepiride
17564
Intervention_Pharmacological
pioglitazone
17565
Intervention_Pharmacological
glimepiride
17566
Intervention_Pharmacological
glimepiride
17567
Intervention_Pharmacological
pioglitazone
17568
Intervention_Pharmacological
pioglitazone
17569
Intervention_Pharmacological
glimepiride
17570
Intervention_Pharmacological
pioglitazone
17571
Intervention_Pharmacological
glimepiride
17572
Intervention_Pharmacological
pioglitazone
17573
Intervention_Pharmacological
glimepirede
17574
Intervention_Pharmacological
pioglitazone
17575
Intervention_Pharmacological
glimepiride
17576
Intervention_Pharmacological
Pioglitazone
17577
Intervention_Pharmacological
glimepiride
17578
Intervention_Pharmacological
Pioglitazone
17579
Intervention_Pharmacological
glimepiride
17580
Intervention_Pharmacological
pioglitazone
17581
Intervention_Pharmacological
glimepiride
17582
Intervention_Pharmacological
pioglitazone
17583
Intervention_Pharmacological
glimepiride
17584
Intervention_Pharmacological
pioglitazone
17585
Outcome_Physical
reductions in HbA ( 1c )
17586
Outcome_Physical
HbA ( 1c )
17587
Outcome_Physical
FPG
17588
Outcome_Physical
insulin sensitivity ( reduced insulin resistance )
17589
Outcome_Physical
HOMA-S values
17590
Outcome_Other
tolerated
17591
Outcome_Adverse-effects
peripheral edema
17592
Outcome_Adverse-effects
hypoglycemic episodes
17593
Outcome_Adverse-effects
weight gain
17594
Participant_Condition
Mexican
17595
Participant_Condition
type 2 diabetes mellitus
17596
Participant_Sample-size
Two hundred forty-four
17597
Participant_Sample-size
125
17598
Participant_Sex
women
17599
Participant_Sample-size
119
17600
Participant_Sex
men
17601
Participant_Condition
all but 1 Hispanic