J Clin Med Res

Journal of Clinical Medicine Research, ISSN 1918-3003 print, 1918-3011 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Clin Med Res and Elmer Press Inc

Journal website http://www.jocmr.org

Original Article

Volume 8, Number 5, May 2016, pages 373-378

Factors Influencing Changes in Hemoglobin A1c and Body Weight During Treatment of Type 2 Diabetes With Ipragliflozin: Interim Analysis of the ASSIGN-K Study

**Table 1.** Characteristics of the Patients
Characteristics
SD: standard deviation; BMI: body mass index; HbA1c: hemoglobin A1c; NGSP: National Glycohemoglobin Standardization Program; eGFR: estimated glomerular filtration rate.
Number	257
Age, mean ± SD	53.9 ± 10.4
< 65 years, n (%)	215 (83.7)
≥ 65 years, n (%)	42 (16.3)
Sex
Male, n (%)	123 (47.9)
Female, n (%)	134 (52.1)
Weight, kg, mean ± SD	80.3 ± 17.4
BMI, kg/m², mean ± SD	30.0 ± 5.4
HbA1c, % (NGSP), mean ± SD (n)	8.2 ± 1.5 (254)
Fasting glucose, mg/dL, mean ± SD (n)	158.5 ± 43.6 (110)
Postprandial glucose, mg/dL, mean ± SD (n)	199.1 ± 85.2 (93)
Duration of diabetes, years, mean ± SD (n)	9.6 ± 6.9 (248)
Systolic blood pressure, mm Hg, mean ± SD (n)	131.3 ± 15.9 (254)
Diastolic blood pressure, mm Hg, mean ± SD (n)	78.3 ± 10.6 (254)
eGFR, mL/min/1.73 m², mean ± SD	83.89 ± 21.67
< 60 mL/min/1.73 m², n (%)	31 (12.3)
≥ 60 mL/min/1.73 m², n (%)	222 (87.7)
Drinking alcohol
Yes, number (%)	87 (33.9)
No, number (%)	169 (65.8)
Smoking tobacco
Yes, number (%)	78 (30.4)
No, number (%)	178 (69.3)

Table 1. Characteristics of the Patients

Characteristics

SD: standard deviation; BMI: body mass index; HbA1c: hemoglobin A1c; NGSP: National Glycohemoglobin Standardization Program; eGFR: estimated glomerular filtration rate.

Number

257

Age, mean ± SD

53.9 ± 10.4

< 65 years, n (%)

215 (83.7)

≥ 65 years, n (%)

42 (16.3)

Sex

Male, n (%)

123 (47.9)

Female, n (%)

134 (52.1)

Weight, kg, mean ± SD

80.3 ± 17.4

BMI, kg/m², mean ± SD

30.0 ± 5.4

HbA1c, % (NGSP), mean ± SD (n)

8.2 ± 1.5 (254)

Fasting glucose, mg/dL, mean ± SD (n)

158.5 ± 43.6 (110)

Postprandial glucose, mg/dL, mean ± SD (n)

199.1 ± 85.2 (93)

Duration of diabetes, years, mean ± SD (n)

9.6 ± 6.9 (248)

Systolic blood pressure, mm Hg, mean ± SD (n)

131.3 ± 15.9 (254)

Diastolic blood pressure, mm Hg, mean ± SD (n)

78.3 ± 10.6 (254)

eGFR, mL/min/1.73 m², mean ± SD

83.89 ± 21.67

< 60 mL/min/1.73 m², n (%)

31 (12.3)

≥ 60 mL/min/1.73 m², n (%)

222 (87.7)

Drinking alcohol

Yes, number (%)

87 (33.9)

No, number (%)

169 (65.8)

Smoking tobacco

Yes, number (%)

78 (30.4)

No, number (%)

178 (69.3)

**Table 2.** Changes in Parameters Related to Glycemic Control and Body Weight
	n	Baseline	Week 4	Week 12
Analysis of variance: vs. baseline *P < 0.01, week 4 vs. week 12 †P < 0.01. HbA1c: hemoglobin A1c; BMI: body mass index.
HbA1c, %	257	8.23	7.81*	7.55*†
Fasting glucose, mg/dL	110	158.5	139.2*	134.6*
Postprandial glucose, mg/dL	93	199.1	161.0*	154.9*
Body weight, kg	240	79.9	78.8*	78.1*†
BMI, kg/m²	241	29.9	29.5*	29.2*†
Waist circumference, cm	250	101.2	99.9*	99.0*†

Table 2. Changes in Parameters Related to Glycemic Control and Body Weight

Baseline

Week 4

Week 12

Analysis of variance: vs. baseline *P < 0.01, week 4 vs. week 12 †P < 0.01. HbA1c: hemoglobin A1c; BMI: body mass index.

HbA1c, %

257

8.23

7.81*

7.55*†

Fasting glucose, mg/dL

110

158.5

139.2*

134.6*

Postprandial glucose, mg/dL

199.1

161.0*

154.9*

Body weight, kg

240

79.9

78.8*

78.1*†

BMI, kg/m²

241

29.9

29.5*

29.2*†

Waist circumference, cm

250

101.2

99.9*

99.0*†

**Table 3.** Multiple Regression Analysis of Factors Influencing the Change in HbA1c in Week 12
Independent variable	Standardized coefficient β	Partial regression coefficient	P value
n = 243. Stepwise analysis with the following independent variables: age, sex, duration of diabetes, baseline HbA1c, baseline BMI, and treatment category (new monotherapy, concurrent administration, or switching treatment). Dependent variable: decrease in HbA1c. BMI: body mass index; HbA1c: hemoglobin A1c.
Constant	0	2.050	0.0034
Age	0.020	0.002	0.7324
Sex	0.081	0.203	0.1196
Duration of diabetes	0.205	0.037	0.0003
BMI (baseline)	0.080	0.019	0.1213
HbA1c (baseline)	-0.585	-0.485	< 0.0001
Switching treatment	0.206	0.806	< 0.0001

Table 3. Multiple Regression Analysis of Factors Influencing the Change in HbA1c in Week 12

Independent variable

Standardized coefficient β

Partial regression coefficient

P value

n = 243. Stepwise analysis with the following independent variables: age, sex, duration of diabetes, baseline HbA1c, baseline BMI, and treatment category (new monotherapy, concurrent administration, or switching treatment). Dependent variable: decrease in HbA1c. BMI: body mass index; HbA1c: hemoglobin A1c.

Constant

2.050

0.0034

Age

0.020

0.002

0.7324

Sex

0.081

0.203

0.1196

Duration of diabetes

0.205

0.037

0.0003

BMI (baseline)

0.080

0.019

0.1213

HbA1c (baseline)

-0.585

-0.485

< 0.0001

Switching treatment

0.206

0.806

< 0.0001

**Table 4.** Multiple Regression Analysis of Factors Influencing the Change in Body Weight in Week 12
Independent variable	Standardized coefficient β	Partial regression coefficient	P value
n = 238. Stepwise analysis with the following independent variables: age, sex, duration of diabetes, baseline HbA1c, and baseline BMI. Dependent variable: decrease in body weight. BMI: body mass index; HbA1c: hemoglobin A1c.
Constant	0	-0.117	0.9422
Age	-0.065	-0.015	0.3714
Sex	-0.092	-0.436	0.1447
Duration of diabetes	0.051	0.018	0.4502
BMI (baseline)	-0.237	-0.111	0.0002
HbA1c (baseline)	0.215	0.334	0.0005

Table 4. Multiple Regression Analysis of Factors Influencing the Change in Body Weight in Week 12

Independent variable

Standardized coefficient β

Partial regression coefficient

P value

n = 238. Stepwise analysis with the following independent variables: age, sex, duration of diabetes, baseline HbA1c, and baseline BMI. Dependent variable: decrease in body weight. BMI: body mass index; HbA1c: hemoglobin A1c.

Constant

-0.117

0.9422

Age

-0.065

-0.015

0.3714

Sex

-0.092

-0.436

0.1447

Duration of diabetes

0.051

0.018

0.4502

BMI (baseline)

-0.237

-0.111

0.0002

HbA1c (baseline)

0.215

0.334

0.0005