Diabetes 2013 May (2)-13

A new preventive strategy for hypoglycemia incorporating added food diet in patients with type 2 diabetes who received sitagliptin therapy.

Endocr Res. 2012;37(4):175-81.

Meguro S, Sano M, Kawai T, Matsuhashi T, Mogi S, Fukuda K, Itoh H, Suzuki Y.

Division of Endocrinology, Metabolism and Nephrology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan. shumeg@z8.keio.jp

Abstract

There has been concern as to whether dipeptidyl peptidase-4 (DPP-4) inhibitors can be used safely in patients with relatively good glycemic control. This study, approved by the institutional review board of Hanzoumon Diabetes City Atlas Clinic, examined whether DPP-4 inhibitor sitagliptin could safely achieve good glycemic control without severe hypoglycemia by employing the “added food” concept. The subjects were 60 patients (46 men and 14 women) with type 2 diabetes who started sitagliptin therapy during a 1-month period from December 15, 2009 to January 15, 2010. They were recommended to have added food between meals to prevent hypoglycemia, while maintaining the same daily calorie intake. HbA(1c) decreased from 7.1 ± 1.2% to 6.5 ± 0.6% after 6 months of sitagliptin treatment (p < 0.001). In patients with a baseline HbA(1c) <7%, it decreased from 6.5 ± 0.3% to 6.1 ± 0.4% (p < 0.001). Systolic blood pressure was significantly reduced from 127.7 ± 17.0 to 122.7 ± 17.9 mmHg in the patients with a baseline HbA(1c) < 7% (p = 0.018). However, body weight increased by approximately 900 g and high-density lipoprotein cholesterol decreased significantly from 1.57 ± 0.46 to 1.43 ± 0.35 mmol/L (p < 0.01) in the patients concomitantly receiving sulfonylureas with sitagliptin. Excellent glycemic control was achieved by sitagliptin treatment together with the added food concept. However, combined use of sitagliptin with sulfonylureas requires attention to weight gain and the lipid profile. Further clinical studies will elucidate whether sitagliptin can decrease cardiovascular events as well as normalizing blood glucose and lowering the blood pressure.

PMID: 22621443

 

Table 1. Background factors of the patients

Sex

Male 46 female 14

Age (years)

62.0 ± 10.1

Duration of diabetes (years)

11.1 ± 9.7

Height (cm)

165.9 ± 9.1

BW (kg)

68.0 ± 12.0

BMI

24.7 ± 3.4

HbA1c (%)

7.1 ± 1.2

SBP (mmHg)

128 ± 17

DBP (mmHg)

77 ± 11

HDL-C (mg/dL)

60.5 ± 17.8

LDL-C (mg/dL)

105.4 ± 25.9

TG (mg/dL)

124.0 ± 74.2

AST (IU/L)

25.1 ± 12.4

ALT (IU/L)

25.8 ± 16.7

gGTP (IU/L)

37.1 ± 31.6

Diabetic retinopathy

no 58 background 2

Diabetic nephropathy

no 52 m-alb 5 M-alb 3

Diabetic neuropathy

no 56 yes 4

BW: body weight, SBP: systolic blood pressure, DBP: diastolic blood pressure, HDL-C: high-density lipoprotein-cholesterol, LDL-C: low-density lipoprotein-cholesterol, TG: triglycerides, AST: aspartate aminotransferase, ALT: alanine aminotransferase, gGTP: gglutamyl transpeptidase, M-alb: macroalbuminuria, m-alb: microalbuminuria.

 

Table 2: Additional medications for diabetes mellitus combined with sitagliptin.

none

18

TZD

1

Glinide

2

SU

16

BG

1

Glinide+BG

1

SU+BG

8

SU+TZD

6

SU+BG+TZD

6

Alpha-glucosidase inhibitors were replaced by sitagliptin at the beginning of the study.

Abbreviations; TZD: thiazolidinedione, BG: biguanide, SU: sulfonylurea

 

Table 3. Changes of parameters after 6 months of sitagliptin treatment

Parameter

0 months

6 months

p value

All (n=60 (M/W: 46/14)

 

 

 

BW (kg)

68.0 ± 12.0

68.9 ± 12.4

<0.01

BMI (kg/m2)

24.7 ± 3.4

25.0 ± 3.5

<0.01

SBP (mmHg)

128 ±17

125 ± 17

n.s.

DBP (mmHg)

77 ± 11

75 ± 12

n.s.

HbA1c (%)

7.1 ± 1.2

6.5 ± 0.6

<0.001

LDL-C (mg/dL)

105.4 ± 25.9

108.9 ± 28.0

n.s.

HDL-C (mg/dL)

60.5 ± 17.8

55.1 ± 13.7

<0.01.

TG (mg/dL)

124 ± 74

148 ± 121

n.s.

Data are expressed as the mean ± SD. Parameters were compared between 0 months and 6 months of treatment by Wilcoxon’s matched-pair signed-rank test.

Abbreviations; BW: body weight, SBP: systolic blood pressure, DBP: diastolic blood pressure, HDL-C: high-density lipoprotein-cholesterol, LDL-C: low-density lipoprotein-cholesterol, TG: triglycerides

 

Table 4. Changes of parameters after 6 months of sitagliptin treatment in patients stratified by baseline HbA1c

Parameters

0 months

6 month

p value

HbA1c³7% (n=25)

 

 

 

BW (kg)

70.6 ± 13.3

71.9 ± 14.1

<0.05

BMI (kg/m2)

25.4 ± 3.7

25.8 ± 3.8

<0.05

SBP (mmHg)

126 ±17

128 ± 14

n.s.

DBP (mmHg)

76 ± 12

75 ± 12

n.s.

HbA1c (%)

8.1 ± 1.3

7.0 ± 0.5

<0.001

LDL-C (mg/dL)

110.0 ± 31.5

108.5 ± 30.5

n.s.

HDL-C (mg/dL)

62.6 ± 21.5

55.5 ± 12.7

<0.01.

TG (mg/dL)

145 ± 79

148 ± 121

n.s.

 

 

 

 

HbA1c<7% (n=35)

 

 

 

BW (kg)

66.2 ± 10.9

66.8 ± 10.8

n.s.

BMI (kg/m2)

24.2 ± 3.1

24.4 ± 3.1

n.s.

SBP (mmHg)

128 ±17

123 ± 18

<0.05

DBP (mmHg)

77 ± 10

74 ± 12

n.s.

HbA1c (%)

6.5 ± 0.3

6.1 ± 0.4

<0.001

LDL-C (mg/dL)

102.1 ± 20.8

108.9 ± 26.5

n.s.

HDL-C (mg/dL)

59.0 ± 14.9

54.7 ± 14.6

<0.01.

TG (mg/dL)

109 ± 67

146 ± 112

n.s.

Data are expressed as the mean ± SD. Parameters were compared between 0 months and 6 months of treatment by Wilcoxon’s matched-pair signed-rank test.

Abbreviations; BW: body weight, SBP: systolic blood pressure, DBP: diastolic blood pressure, HDL-C: high-density lipoprotein-cholesterol, LDL-C: low-density lipoprotein-cholesterol, TG: triglycerides

 

Table 5. Changes of parameters after 6 months of sitagliptin treatment in patients with or without combined SU therapy

Parameter

0 months

6 months

p value

With SU therapy (n=36)

 

 

 

BW (kg)

69.9 ± 11.9

71.2 ± 12.5

<0.01

BMI (kg/m2)

25.0 ± 6.7

25.5 ± 3.5

<0.01

SBP (mmHg)

132 ±16

130 ± 16

n.s.

DBP (mmHg)

78 ± 11

76 ± 10

n.s.

HbA1c (%)

7.4 ± 1.2

6.7 ± 0.5

<0.001

LDL-C (mg/dL)

107.8 ± 27.2

110.0 ± 29.4

n.s.

HDL-C (mg/dL)

62.1 ± 19.1

54.6 ± 12.3

<0.01.

TG (mg/dL)

120 ± 71

151 ± 132

n.s.

 

 

 

 

Without SU therapy (n=24)

 

 

 

BW (kg)

65.4 ± 12.0

65.6 ± 11.8

n.s.

BMI (kg/m2)

24.3 ± 3.4

24.4 ± 3.3

n.s.

SBP (mmHg)

122 ± 17

118 ± 14

n.s.

DBP (mmHg)

74 ± 10

73 ± 14

n.s.

HbA1c (%)

6.8 ± 1.0

6.2 ± 0.6

<0.001

LDL-C (mg/dL)

101.9± 23.4

107.0 ± 26.2

n.s.

HDL-C (mg/dL)

58.0 ± 15.8

55.7 ± 15.8

n.s.

TG (mg/dL)

131 ± 79

143 ± 106

n.s.

Data are expressed as the mean ± SD. Parameters were compared between 0 months and 6 months of treatment by Wilcoxon’s matched-pair signed-rank test.

Abbreviations; BW: body weight, SBP: systolic blood pressure, DBP: diastolic blood pressure, HDL-C: high-density lipoprotein-cholesterol, LDL-C: low-density lipoprotein-cholesterol, TG: triglycerides

Changes of HbA1c after 6 months of sitagliptin treatment

 Shu Meguro-1

 

 

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