Comparison between repaglinide and glimepiride in patients with type 2 diabetes mellitus

A one-year, randomized, double-blind assessment of metabolic parameters and cardiovascular risk factor

Giuseppe Derosa, Amedeo Mugellini, Leonardina Ciccarelli, Giuseppe Crescenzi, Roberto Fogari

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65 Citations (Scopus)

Abstract

Background: Repaglinide and glimepiride are relatively new oral hypoglycemic agents. Few data are available concerning their effects on metabolic parameters other than measures of glycemic control. Objectives: In addition to assessing the effects of repaglinide and glimepiride on glycemic control in patients with type 2 diabetes mellitus, this study also examined the effects of these agents on 3 metabolic parameters known to be cardiovascular risk factors - lipoprotein(a) (Lp [a]), plasminogen activator inhibitor-1 (PAI-1), and homocysteine (Hcy). Methods: This randomized, placebo-controlled, double-blind trial was conducted at a single center in Italy. Eligible patients were nonsmokers; had no hypertension or coronary heart disease; were taking no hypolipidemic drugs, diuretics, beta-blockers, or thyroxin; and had normal renal function. After an initial 4-week placebo washout period, patients were randomized to receive repaglinide 1 mg/d or glimepiride 1 mg/d. The dose of study drug was optimized over an 8-week titration period, which was followed by a 12-month treatment period. Measures of glycemic control (glycated hemoglobin [HbA1c], fasting plasma glucose [FPG], postprandial plasma glucose [PPG], fasting plasma insulin [FPI], postprandial plasma insulin [PPI]) and the other metabolic parameters of interest were assessed after 6 and 12 months of treatment. Results: One hundred twenty-four patients (63 women, 61 men) completed the study, 62 in each treatment group. There were no significant differences in demographic characteristics between groups. After 6 and 12 months of treatment, FPG levels and HbA1c values were significantly reduced from baseline in both groups (6 months, P ≤ 0.05; 12 months, P ≤ 0.01). After 6 months, PPG levels were significantly decreased only in the repaglinide group (P ≤ 0.05 vs baseline); at 12 months, however, PPG levels were significantly reduced from baseline in both groups (P ≤ 0.01 repaglinide, P ≤ 0.05 glimepiride). No significant changes from baseline in FPI or PPI levels were seen in either group at 6 months, although FPI levels were significantly increased in the repaglinide group at 12 months (P ≤ 0.05). Repaglinide significantly lowered levels of Lp(a), PAI-1, and Hcy after 12 months (all, P ≤ 0.05 vs baseline). Glimepiride significantly lowered levels of Lp(a) and Hcy after 6 months (both, P ≤ 0.05 vs baseline) and levels of Lp(a) (P ≤ 0.01 vs baseline), Hcy (P ≤ 0.01 vs baseline), and PAI-1 (P ≤ 0.05 vs baseline) after 12 months. Conclusions: Repaglinide and glimepiride improved glycemic control and reduced levels of other metabolic parameters of interest in this population of patients with type 2 diabetes. It is possible that the reductions in Lp(a), PAI-1, and Hcy were the result of improved glucose metabolism; however, the possibility that repaglinide and glimepiride may have a direct effect on these parameters should not be excluded.

Original languageEnglish
Pages (from-to)472-484
Number of pages13
JournalClinical Therapeutics
Volume25
Issue number2
DOIs
Publication statusPublished - Feb 1 2003

Fingerprint

repaglinide
glimepiride
Type 2 Diabetes Mellitus
Homocysteine
Plasminogen Activator Inhibitor 1
Fasting
Glucose
Insulin
Placebos
Hypolipidemic Agents
Lipoprotein(a)

Keywords

  • Glimepiride
  • Homocysteine
  • Lipoprotein(a)
  • Plasma
  • Plasminogen activator inhibitor-1
  • Repaglinide

ASJC Scopus subject areas

  • Pharmacology

Cite this

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title = "Comparison between repaglinide and glimepiride in patients with type 2 diabetes mellitus: A one-year, randomized, double-blind assessment of metabolic parameters and cardiovascular risk factor",
abstract = "Background: Repaglinide and glimepiride are relatively new oral hypoglycemic agents. Few data are available concerning their effects on metabolic parameters other than measures of glycemic control. Objectives: In addition to assessing the effects of repaglinide and glimepiride on glycemic control in patients with type 2 diabetes mellitus, this study also examined the effects of these agents on 3 metabolic parameters known to be cardiovascular risk factors - lipoprotein(a) (Lp [a]), plasminogen activator inhibitor-1 (PAI-1), and homocysteine (Hcy). Methods: This randomized, placebo-controlled, double-blind trial was conducted at a single center in Italy. Eligible patients were nonsmokers; had no hypertension or coronary heart disease; were taking no hypolipidemic drugs, diuretics, beta-blockers, or thyroxin; and had normal renal function. After an initial 4-week placebo washout period, patients were randomized to receive repaglinide 1 mg/d or glimepiride 1 mg/d. The dose of study drug was optimized over an 8-week titration period, which was followed by a 12-month treatment period. Measures of glycemic control (glycated hemoglobin [HbA1c], fasting plasma glucose [FPG], postprandial plasma glucose [PPG], fasting plasma insulin [FPI], postprandial plasma insulin [PPI]) and the other metabolic parameters of interest were assessed after 6 and 12 months of treatment. Results: One hundred twenty-four patients (63 women, 61 men) completed the study, 62 in each treatment group. There were no significant differences in demographic characteristics between groups. After 6 and 12 months of treatment, FPG levels and HbA1c values were significantly reduced from baseline in both groups (6 months, P ≤ 0.05; 12 months, P ≤ 0.01). After 6 months, PPG levels were significantly decreased only in the repaglinide group (P ≤ 0.05 vs baseline); at 12 months, however, PPG levels were significantly reduced from baseline in both groups (P ≤ 0.01 repaglinide, P ≤ 0.05 glimepiride). No significant changes from baseline in FPI or PPI levels were seen in either group at 6 months, although FPI levels were significantly increased in the repaglinide group at 12 months (P ≤ 0.05). Repaglinide significantly lowered levels of Lp(a), PAI-1, and Hcy after 12 months (all, P ≤ 0.05 vs baseline). Glimepiride significantly lowered levels of Lp(a) and Hcy after 6 months (both, P ≤ 0.05 vs baseline) and levels of Lp(a) (P ≤ 0.01 vs baseline), Hcy (P ≤ 0.01 vs baseline), and PAI-1 (P ≤ 0.05 vs baseline) after 12 months. Conclusions: Repaglinide and glimepiride improved glycemic control and reduced levels of other metabolic parameters of interest in this population of patients with type 2 diabetes. It is possible that the reductions in Lp(a), PAI-1, and Hcy were the result of improved glucose metabolism; however, the possibility that repaglinide and glimepiride may have a direct effect on these parameters should not be excluded.",
keywords = "Glimepiride, Homocysteine, Lipoprotein(a), Plasma, Plasminogen activator inhibitor-1, Repaglinide",
author = "Giuseppe Derosa and Amedeo Mugellini and Leonardina Ciccarelli and Giuseppe Crescenzi and Roberto Fogari",
year = "2003",
month = "2",
day = "1",
doi = "10.1016/S0149-2918(03)80090-5",
language = "English",
volume = "25",
pages = "472--484",
journal = "Clinical Therapeutics",
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TY - JOUR

T1 - Comparison between repaglinide and glimepiride in patients with type 2 diabetes mellitus

T2 - A one-year, randomized, double-blind assessment of metabolic parameters and cardiovascular risk factor

AU - Derosa, Giuseppe

AU - Mugellini, Amedeo

AU - Ciccarelli, Leonardina

AU - Crescenzi, Giuseppe

AU - Fogari, Roberto

PY - 2003/2/1

Y1 - 2003/2/1

N2 - Background: Repaglinide and glimepiride are relatively new oral hypoglycemic agents. Few data are available concerning their effects on metabolic parameters other than measures of glycemic control. Objectives: In addition to assessing the effects of repaglinide and glimepiride on glycemic control in patients with type 2 diabetes mellitus, this study also examined the effects of these agents on 3 metabolic parameters known to be cardiovascular risk factors - lipoprotein(a) (Lp [a]), plasminogen activator inhibitor-1 (PAI-1), and homocysteine (Hcy). Methods: This randomized, placebo-controlled, double-blind trial was conducted at a single center in Italy. Eligible patients were nonsmokers; had no hypertension or coronary heart disease; were taking no hypolipidemic drugs, diuretics, beta-blockers, or thyroxin; and had normal renal function. After an initial 4-week placebo washout period, patients were randomized to receive repaglinide 1 mg/d or glimepiride 1 mg/d. The dose of study drug was optimized over an 8-week titration period, which was followed by a 12-month treatment period. Measures of glycemic control (glycated hemoglobin [HbA1c], fasting plasma glucose [FPG], postprandial plasma glucose [PPG], fasting plasma insulin [FPI], postprandial plasma insulin [PPI]) and the other metabolic parameters of interest were assessed after 6 and 12 months of treatment. Results: One hundred twenty-four patients (63 women, 61 men) completed the study, 62 in each treatment group. There were no significant differences in demographic characteristics between groups. After 6 and 12 months of treatment, FPG levels and HbA1c values were significantly reduced from baseline in both groups (6 months, P ≤ 0.05; 12 months, P ≤ 0.01). After 6 months, PPG levels were significantly decreased only in the repaglinide group (P ≤ 0.05 vs baseline); at 12 months, however, PPG levels were significantly reduced from baseline in both groups (P ≤ 0.01 repaglinide, P ≤ 0.05 glimepiride). No significant changes from baseline in FPI or PPI levels were seen in either group at 6 months, although FPI levels were significantly increased in the repaglinide group at 12 months (P ≤ 0.05). Repaglinide significantly lowered levels of Lp(a), PAI-1, and Hcy after 12 months (all, P ≤ 0.05 vs baseline). Glimepiride significantly lowered levels of Lp(a) and Hcy after 6 months (both, P ≤ 0.05 vs baseline) and levels of Lp(a) (P ≤ 0.01 vs baseline), Hcy (P ≤ 0.01 vs baseline), and PAI-1 (P ≤ 0.05 vs baseline) after 12 months. Conclusions: Repaglinide and glimepiride improved glycemic control and reduced levels of other metabolic parameters of interest in this population of patients with type 2 diabetes. It is possible that the reductions in Lp(a), PAI-1, and Hcy were the result of improved glucose metabolism; however, the possibility that repaglinide and glimepiride may have a direct effect on these parameters should not be excluded.

AB - Background: Repaglinide and glimepiride are relatively new oral hypoglycemic agents. Few data are available concerning their effects on metabolic parameters other than measures of glycemic control. Objectives: In addition to assessing the effects of repaglinide and glimepiride on glycemic control in patients with type 2 diabetes mellitus, this study also examined the effects of these agents on 3 metabolic parameters known to be cardiovascular risk factors - lipoprotein(a) (Lp [a]), plasminogen activator inhibitor-1 (PAI-1), and homocysteine (Hcy). Methods: This randomized, placebo-controlled, double-blind trial was conducted at a single center in Italy. Eligible patients were nonsmokers; had no hypertension or coronary heart disease; were taking no hypolipidemic drugs, diuretics, beta-blockers, or thyroxin; and had normal renal function. After an initial 4-week placebo washout period, patients were randomized to receive repaglinide 1 mg/d or glimepiride 1 mg/d. The dose of study drug was optimized over an 8-week titration period, which was followed by a 12-month treatment period. Measures of glycemic control (glycated hemoglobin [HbA1c], fasting plasma glucose [FPG], postprandial plasma glucose [PPG], fasting plasma insulin [FPI], postprandial plasma insulin [PPI]) and the other metabolic parameters of interest were assessed after 6 and 12 months of treatment. Results: One hundred twenty-four patients (63 women, 61 men) completed the study, 62 in each treatment group. There were no significant differences in demographic characteristics between groups. After 6 and 12 months of treatment, FPG levels and HbA1c values were significantly reduced from baseline in both groups (6 months, P ≤ 0.05; 12 months, P ≤ 0.01). After 6 months, PPG levels were significantly decreased only in the repaglinide group (P ≤ 0.05 vs baseline); at 12 months, however, PPG levels were significantly reduced from baseline in both groups (P ≤ 0.01 repaglinide, P ≤ 0.05 glimepiride). No significant changes from baseline in FPI or PPI levels were seen in either group at 6 months, although FPI levels were significantly increased in the repaglinide group at 12 months (P ≤ 0.05). Repaglinide significantly lowered levels of Lp(a), PAI-1, and Hcy after 12 months (all, P ≤ 0.05 vs baseline). Glimepiride significantly lowered levels of Lp(a) and Hcy after 6 months (both, P ≤ 0.05 vs baseline) and levels of Lp(a) (P ≤ 0.01 vs baseline), Hcy (P ≤ 0.01 vs baseline), and PAI-1 (P ≤ 0.05 vs baseline) after 12 months. Conclusions: Repaglinide and glimepiride improved glycemic control and reduced levels of other metabolic parameters of interest in this population of patients with type 2 diabetes. It is possible that the reductions in Lp(a), PAI-1, and Hcy were the result of improved glucose metabolism; however, the possibility that repaglinide and glimepiride may have a direct effect on these parameters should not be excluded.

KW - Glimepiride

KW - Homocysteine

KW - Lipoprotein(a)

KW - Plasma

KW - Plasminogen activator inhibitor-1

KW - Repaglinide

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U2 - 10.1016/S0149-2918(03)80090-5

DO - 10.1016/S0149-2918(03)80090-5

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