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Nateglinide and glibenclamide metabolic effects in naïve type 2 diabetic patients treated with metformin.
J Clin Pharm Ther. 2009 Feb; 34(1):13-23.JC

Abstract

BACKGROUND AND OBJECTIVE

Most antidiabetic agents target only one of several underlying causes of diabetes. The complementary actions of the glinides and the biguanides may give optimal glycemic control in patients with type 2 diabetes mellitus. The aim of the present study was to compare the effects of nateglinide plus metformin with glibenclamide plus metformin on glucose and lipid metabolism, and haemodynamic parameters in patients with type 2 diabetes mellitus.

METHODS

We enrolled 248 type 2 diabetic patients. Patients were randomly assigned to receive nateglinide (n = 124) or glibenclamide (n = 124), after 6 months of run-in, in which we titrated nateglinide (starting dose 180 mg/day), glibenclamide (starting dose 7.5 mg/day), and metformin (starting dose 1500 mg/day). The final doses were (mean +/- standard deviation), 300 +/- 60, 12.5 +/- 2.5, and 2500 +/- 500 mg/day, respectively. We followed these patients for 1 year after titration. We assessed body mass index (BMI), fasting (FPG) and post-prandial (PPG) plasma glucose, glycosylated haemoglobin (HbA(1c)), fasting (FPI) and post-prandial (PPI) plasma insulin, homeostasis model assessment (HOMA) index, and lipid profile [total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), triglycerides (Tg), apolipoprotein A-I (Apo A-I), and apolipoprotein B (Apo B)], systolic blood pressure (SBP), and diastolic blood pressure (DBP). All variables were evaluated at baseline and after 3 and 6 months in the run-in period, and at baseline, and after 3, 6, 9 and 12 months for both treatment groups.

RESULTS AND DISCUSSION

Body mass index did not show any significant change during the study. We observed a significant improvement from baseline to 1 year on HbA(1c) (P < 0.01 vs. baseline and vs. glibenclamide group, respectively), FPG (P < 0.01 vs. baseline), PPG (P < 0.01 vs. baseline), and on HOMA index (P < 0.05 vs. baseline) in the nateglinide group. In the glibenclamide group, we found significant changes in HbA(1c) (P < 0.05 vs. baseline), FPG (P < 0.01 vs. baseline), PPG (P < 0.05 vs. baseline), and HOMA index (P < 0.05 vs. baseline). No significant change was observed in TC, LDL-C, HDL-C, Tg, Apo A-I, Apo B, SBP, DBP and HR in either group after 3, 6, 9 and 12 months. These effects of nateglinide and glibenclamide on insulin-resistance parameters are in agreement with previous reports. Contrarily to previous reports, we did not observe any significant BP change in patients treated with glibenclamide. Although both nateglinide and glibenclamide attenuated PPG and HOMA index, they did not have significant effects on lipid metabolism, as already shown in subjects with type 2 diabetes and good glycemic control.

CONCLUSION

Nateglinide improved glycemic control better than glibenclamide in combination with metformin.

Authors+Show Affiliations

Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy. giuseppe.derosa@uni.pv.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

19125899

Citation

Derosa, G, et al. "Nateglinide and Glibenclamide Metabolic Effects in Naïve Type 2 Diabetic Patients Treated With Metformin." Journal of Clinical Pharmacy and Therapeutics, vol. 34, no. 1, 2009, pp. 13-23.
Derosa G, D'Angelo A, Fogari E, et al. Nateglinide and glibenclamide metabolic effects in naïve type 2 diabetic patients treated with metformin. J Clin Pharm Ther. 2009;34(1):13-23.
Derosa, G., D'Angelo, A., Fogari, E., Salvadeo, S., Gravina, A., Ferrari, I., & Cicero, A. F. (2009). Nateglinide and glibenclamide metabolic effects in naïve type 2 diabetic patients treated with metformin. Journal of Clinical Pharmacy and Therapeutics, 34(1), 13-23. https://doi.org/10.1111/j.1365-2710.2008.00984.x
Derosa G, et al. Nateglinide and Glibenclamide Metabolic Effects in Naïve Type 2 Diabetic Patients Treated With Metformin. J Clin Pharm Ther. 2009;34(1):13-23. PubMed PMID: 19125899.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nateglinide and glibenclamide metabolic effects in naïve type 2 diabetic patients treated with metformin. AU - Derosa,G, AU - D'Angelo,A, AU - Fogari,E, AU - Salvadeo,S, AU - Gravina,A, AU - Ferrari,I, AU - Cicero,A F G, PY - 2009/1/8/entrez PY - 2009/1/8/pubmed PY - 2009/2/27/medline SP - 13 EP - 23 JF - Journal of clinical pharmacy and therapeutics JO - J Clin Pharm Ther VL - 34 IS - 1 N2 - BACKGROUND AND OBJECTIVE: Most antidiabetic agents target only one of several underlying causes of diabetes. The complementary actions of the glinides and the biguanides may give optimal glycemic control in patients with type 2 diabetes mellitus. The aim of the present study was to compare the effects of nateglinide plus metformin with glibenclamide plus metformin on glucose and lipid metabolism, and haemodynamic parameters in patients with type 2 diabetes mellitus. METHODS: We enrolled 248 type 2 diabetic patients. Patients were randomly assigned to receive nateglinide (n = 124) or glibenclamide (n = 124), after 6 months of run-in, in which we titrated nateglinide (starting dose 180 mg/day), glibenclamide (starting dose 7.5 mg/day), and metformin (starting dose 1500 mg/day). The final doses were (mean +/- standard deviation), 300 +/- 60, 12.5 +/- 2.5, and 2500 +/- 500 mg/day, respectively. We followed these patients for 1 year after titration. We assessed body mass index (BMI), fasting (FPG) and post-prandial (PPG) plasma glucose, glycosylated haemoglobin (HbA(1c)), fasting (FPI) and post-prandial (PPI) plasma insulin, homeostasis model assessment (HOMA) index, and lipid profile [total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), triglycerides (Tg), apolipoprotein A-I (Apo A-I), and apolipoprotein B (Apo B)], systolic blood pressure (SBP), and diastolic blood pressure (DBP). All variables were evaluated at baseline and after 3 and 6 months in the run-in period, and at baseline, and after 3, 6, 9 and 12 months for both treatment groups. RESULTS AND DISCUSSION: Body mass index did not show any significant change during the study. We observed a significant improvement from baseline to 1 year on HbA(1c) (P < 0.01 vs. baseline and vs. glibenclamide group, respectively), FPG (P < 0.01 vs. baseline), PPG (P < 0.01 vs. baseline), and on HOMA index (P < 0.05 vs. baseline) in the nateglinide group. In the glibenclamide group, we found significant changes in HbA(1c) (P < 0.05 vs. baseline), FPG (P < 0.01 vs. baseline), PPG (P < 0.05 vs. baseline), and HOMA index (P < 0.05 vs. baseline). No significant change was observed in TC, LDL-C, HDL-C, Tg, Apo A-I, Apo B, SBP, DBP and HR in either group after 3, 6, 9 and 12 months. These effects of nateglinide and glibenclamide on insulin-resistance parameters are in agreement with previous reports. Contrarily to previous reports, we did not observe any significant BP change in patients treated with glibenclamide. Although both nateglinide and glibenclamide attenuated PPG and HOMA index, they did not have significant effects on lipid metabolism, as already shown in subjects with type 2 diabetes and good glycemic control. CONCLUSION: Nateglinide improved glycemic control better than glibenclamide in combination with metformin. SN - 1365-2710 UR - https://www.unboundmedicine.com/medline/citation/19125899/Nateglinide_and_glibenclamide_metabolic_effects_in_naïve_type_2_diabetic_patients_treated_with_metformin_ L2 - https://doi.org/10.1111/j.1365-2710.2008.00984.x DB - PRIME DP - Unbound Medicine ER -