Comparison of Efficacy and Safety of the Domestic Nateglinide with Repaglinide on Type 2 Diabetes Mellitus-Multi-Centre, Double-Blind, Dummy, Randomised Clinical Trial_Chinese Journal of Evidence-Based Medicine

Authors：

TIAN Hao ming ¹ , LI Qifu ² , WANG Naizun ³ , WU Tong ⁴ , LIU Ya ⁵ , NI Zongzan ⁶ , YU Hongling ¹ , LI Jianwei ¹ , LUO Rong ² , LI Yingrong ³ , HUANG Lianchuan ⁴ , XIA Yan ⁶

Corresponding author：

Keywords：

Na teglinide; Repaglinide; Type 2 diabetes mellitus; Randomized controlled trial; D rug treatment

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective 　To evaluate efficacy and safety of domestic Nateglinide tablet in comparison with domestic Repaglinide in Type 2 diabeties.
Methods 　A multi-centre, double-blind, dummy trial was conducted.Two hundred and thirty type 2 diabetic patients recuited from 5 clinical centers were randomly allocated into Group A (domestic Repaglinide, 1.0 mg tid, n =115) and Group B (domestic Nateglinide, 90 mg tid, n =115).The trial consisted of a 4 weeksequilibrated period followed by 12 weeks treatment course.
Results 　Ninety seven percent of patients(223) completed the trial (110 in Group A and 113 in Group B). The mean of fasting blood glucose (FBG) in both Group A and B was decreased statistically (P＜ 0.000 1) after 2, 6 and 12 weeks duration. At week 12, the mean FBG in Group A and B was reduced by 1.68±1.81 mmol/L (17.27%) and 1.17±1.67 mmol/L (12.53%) respectively with statistically significant difference between the two groups (P=0.017 7). The mean of 120 minutes postprandial blood glucose (PBG) also lowered markedly in 2, 6, and 12 weeks in both groups. At the end of therapy, PBG of 30, 60, 120 minutes were reduced significantly, mean of 120 minutes PBG was reduced 3.95±3.25 mmol/L (26.12%), and 3.81±3.05 mmol/L (26.22%) respectively in Group A and B , the differences in reduction between Group A and B had no statistical significance (P =0.726 9). In Group A and B, the mean of Alc was reduced significantly after 12 weeks duration. At week 12, the mean of Alc in Group A and B was lowered by 1.21% and 0.68% respectively, with statistical difference between the two groups (P =0.002 3). Though fasting insulin level in both groups had no change after 12 weeks duration, the insulin level at 30, 60 and 120 min increased significantly in both groups (P＜0.000 1). It suggested that both Nateglinide and Repaglinide promoted insulin secretion in early phase with maximal value at 60 min in Repaglinide group and 30 min in Nateglinide group, respectively. The adverse reaction rate in Group A including hypoglycemic reaction, thrombocytopenia and recrudescence of HBV was 4.5% when compared to only one case of thrombocytopenia in Group B (0.87%).
Conclusions 　Both domestic Nateglinide and Repaglinide have similar effect on reducing postprandial blood glucose, but Repaglinide has ber effect on reducing FBG and A1c than Nateglinide. The results suggest that both domestic Nateglinide and Repaglinide are safe and generally well-tolerated in type 2 diabetic patients.

Citation： TIAN Hao ming,LI Qifu,WANG Naizun,WU Tong,LIU Ya,NI Zongzan,YU Hongling,LI Jianwei,LUO Rong,LI Yingrong,HUANG Lianchuan,XIA Yan. Comparison of Efficacy and Safety of the Domestic Nateglinide with Repaglinide on Type 2 Diabetes Mellitus-Multi-Centre, Double-Blind, Dummy, Randomised Clinical Trial. Chinese Journal of Evidence-Based Medicine, 2004, 04(7): 446-452. doi: Copy

1.	［1］Definition,diagnosis and classification of diabetes mellitus and its complications report of WHO consultation Part 1:diagnosis and classification of diabetes mellitus[R].World health organization:Geneva,1999.
2.	［2］Raskin P,Klaff L,McGill J,South SA,Hollander P,Khutoryansky N,Hale P M.Repaglinide vs.Nateglinide Metformin Combination Study Group.Efficacy and Safety of Combination Therapy Repaglinide plus metformin versus nateglinide plus metformin[J].Diabetes Care,2003;26(7):2 063-2 068.
3.	［3］Kalbag JB,Walter YH,Nedelman JR,McLeod JF.Mealtime glucose regulation with nateglinide in healthy volunteers:comparison with repaglinide and placebo[J].Diabetes Care,2001; 24(1):73-80.
4.	［4］Bruttomesso D,Pianta A,Mari A,Valerio A,Marescotti M-C,Avogaro A,Tiengo A,Del Prato S.Restoration of early rise in plasma insulin levels improves the glucose tolerance of type 2 diabetic patients[J].Diabetes,1999; 48(1):99-105.
5.	［5］Kahn SE,Montgomery B,Howell WM,Ligueros-Saylan M,Hsu C,Devineni D,McLeod J,Horowitz AD.Nateglinide increases first phase insulin secretion and enhances glucose clearance in type 2 diabetes[J].Diabetes,2000; 49 (Suppl 1):A113.
6.	［6］Cohen RM,Ramlo-Halsted BA.How do the new insulin secretagogues compare[J].Diabetes Care.2002; 25(8):1472-1475.
7.	［7］Julio Rosenstock,David R.Hassman,Robert D.Madder,et al.Repaglinide Versus Nateglinide Monotherapy A randomized,multicenter study.Diabetes Care,2004 ; 27:1265-1270.
8.	［8］Sato Y,Nishikawa M,Shinkai H,Sukegawa E.Possibility of ideal blood glucose control by a new oral hypoglycemic agent N-[(trans-4-isopropylcyclohexyl)-carbonyl ]-D-phenylalanine (A-4 166),and its stimulatory effect on insulin secretion in animals[J].Diabetes Res Clin Pract,1991; 12(7):53-59.
9.	［9］Karara AH,Dunning BE,McLeod JF.The effect of food on the oral bioavailability and the pharmacodynamic actions of the insulinotropic agent nateglinide in healthy subjects[J].J Clin Pharmacol,1999; 39(11):172-179.
10.	［10］Hu S,Wang S,Fanelli B,Bell PA,Dunning BE,Geisse S,Schmitz R,Boettcher B:Pancreatic β-cell KATP channel activity and membrane binding studies with nateglinide:a comparison with sulfonylureas and repaglinide[J].J Pharmacol Exp Ther,2000;10(293):444-452.

1. ［1］Definition,diagnosis and classification of diabetes mellitus and its complications report of WHO consultation Part 1:diagnosis and classification of diabetes mellitus[R].World health organization:Geneva,1999.
2. ［2］Raskin P,Klaff L,McGill J,South SA,Hollander P,Khutoryansky N,Hale P M.Repaglinide vs.Nateglinide Metformin Combination Study Group.Efficacy and Safety of Combination Therapy Repaglinide plus metformin versus nateglinide plus metformin[J].Diabetes Care,2003;26(7):2 063-2 068.
3. ［3］Kalbag JB,Walter YH,Nedelman JR,McLeod JF.Mealtime glucose regulation with nateglinide in healthy volunteers:comparison with repaglinide and placebo[J].Diabetes Care,2001; 24(1):73-80.
4. ［4］Bruttomesso D,Pianta A,Mari A,Valerio A,Marescotti M-C,Avogaro A,Tiengo A,Del Prato S.Restoration of early rise in plasma insulin levels improves the glucose tolerance of type 2 diabetic patients[J].Diabetes,1999; 48(1):99-105.
5. ［5］Kahn SE,Montgomery B,Howell WM,Ligueros-Saylan M,Hsu C,Devineni D,McLeod J,Horowitz AD.Nateglinide increases first phase insulin secretion and enhances glucose clearance in type 2 diabetes[J].Diabetes,2000; 49 (Suppl 1):A113.
6. ［6］Cohen RM,Ramlo-Halsted BA.How do the new insulin secretagogues compare[J].Diabetes Care.2002; 25(8):1472-1475.
7. ［7］Julio Rosenstock,David R.Hassman,Robert D.Madder,et al.Repaglinide Versus Nateglinide Monotherapy A randomized,multicenter study.Diabetes Care,2004 ; 27:1265-1270.
8. ［8］Sato Y,Nishikawa M,Shinkai H,Sukegawa E.Possibility of ideal blood glucose control by a new oral hypoglycemic agent N-[(trans-4-isopropylcyclohexyl)-carbonyl ]-D-phenylalanine (A-4 166),and its stimulatory effect on insulin secretion in animals[J].Diabetes Res Clin Pract,1991; 12(7):53-59.
9. ［9］Karara AH,Dunning BE,McLeod JF.The effect of food on the oral bioavailability and the pharmacodynamic actions of the insulinotropic agent nateglinide in healthy subjects[J].J Clin Pharmacol,1999; 39(11):172-179.
10. ［10］Hu S,Wang S,Fanelli B,Bell PA,Dunning BE,Geisse S,Schmitz R,Boettcher B:Pancreatic β-cell KATP channel activity and membrane binding studies with nateglinide:a comparison with sulfonylureas and repaglinide[J].J Pharmacol Exp Ther,2000;10(293):444-452.

Chinese Journal of Evidence-Based Medicine

Comparison of Efficacy and Safety of the Domestic Nateglinide with Repaglinide on Type 2 Diabetes Mellitus-Multi-Centre, Double-Blind, Dummy, Randomised Clinical Trial

Abstract Full text Figures/Tables Video References Cited by

Format

Content