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 10, Number 1, January 2018, pages 32-40

Renal Function During an Open-Label Prospective Observational Trial of Sitagliptin in Patients With Diabetes: A Sub-Analysis of the JAMP Study

Figure 1. Study design. *1: criteria for inadequate blood glucose control: HbA1c level ≥ 6.9% or fasting blood glucose level ≥ 130 mg/dL. *2: specific investigational tests (optional): GA, 1.5AG, C-peptide, and proinsulin-to-insulin ratio.

Figure 3. Changes in eGFR (categorized by baseline eGFR). (a) *P < 0.05 vs. 0 M paired t-test. (b) Values presented are mean ± SD.

Figure 4. Changes in HbA1c (categorized by baseline eGFR). (a) eGFR: estimated glomerular filtration rate. *P < 0.05 vs. baseline, paired t-test. (b) Values presented are mean ± SD. N.S. ANOVA.

Figure 5. Change in UACR of patients (n = 53) with a baseline UACR ≥ 30 mg/g Cre. Data are first, second, third quartile. Change at: 3 months: -21.6 (-46.8, 7.8); 12 months: -17.1 (-39.8, 23.8). †P < 0.05 vs. baseline, Wilcoxon signed rank test.

**Table 1.** Clinical Characteristics of Study Patients (n = 651)
Parameter	Mean ± SD or n (%)	Parameter	Mean ± SD or n (%)
Data are represented as the mean ± SD or n (%). BMI: body mass index; T2DM: type 2 diabetes mellitus; HbA1c: glycated hemoglobin; HOMA-IR: homeostatic model assessment for insulin resistance; HOMA-β: homeostatic model assessment for β-cell function; SBP: systolic blood pressure; DBP: diastolic blood pressure; α-GI: α-glucosidase inhibitor.
Age (years)	63.8 ± 11.8	Arteriosclerosis obliterans	55 (8.4)
Sex (male %)	434 (66.7)	Atrial fibrillation	16 (2.5)
BMI (kg/m²)	25.2 ± 4.2	Renal disease	49 (7.5)
Duration of T2DM (years)	8.8 ± 6.7	Hepatic disease	56 (8.6)
Abdominal circumference (cm)	88.3 ± 11.1	Myocardial infarction	18 (2.8)
HbA1c (%)	7.86 ± 1.07	Cerebral stroke	45 (6.9)
Fasting blood glucose (mg/dL)	159.2 ± 41.5	Angina pectoris	27 (4.1)
HOMA-IR	2.83 ± 1.80	Cardiac failure	11 (1.7)
HOMA-β (%)	32.1 ± 27.1	Myocardial infarction	18 (2.8)
C-peptide (ng/mL)	2.10 ± 0.89	Diet/exercise therapy	189 (29)
SBP (mm Hg)	130.9 ± 14.9	Low-dose glimepiride 0.5 - 1.0 mg	72 (11.1)
DBP (mm Hg)	76.5 ± 10.5	Medium-dose glimepiride 1.5 - 2.0 mg	50 (7.7)
Hypertension	393 (60.4)	Biguanide	99 (15.2)
Dyslipidemia	417 (64.1)	Thiazolidine	38 (5.8)
Hyperuricemia	65 (10)	α-GI	18 (2.8)
Retinopathy	48 (7.4)	Multiple-drug co-administration	185 (28.4)

Table 1. Clinical Characteristics of Study Patients (n = 651)

Parameter

Mean ± SD or n (%)

Parameter

Mean ± SD or n (%)

Data are represented as the mean ± SD or n (%). BMI: body mass index; T2DM: type 2 diabetes mellitus; HbA1c: glycated hemoglobin; HOMA-IR: homeostatic model assessment for insulin resistance; HOMA-β: homeostatic model assessment for β-cell function; SBP: systolic blood pressure; DBP: diastolic blood pressure; α-GI: α-glucosidase inhibitor.

Age (years)

63.8 ± 11.8

Arteriosclerosis obliterans

55 (8.4)

Sex (male %)

434 (66.7)

Atrial fibrillation

16 (2.5)

BMI (kg/m²)

25.2 ± 4.2

Renal disease

49 (7.5)

Duration of T2DM (years)

8.8 ± 6.7

Hepatic disease

56 (8.6)

Abdominal circumference (cm)

88.3 ± 11.1

Myocardial infarction

18 (2.8)

HbA1c (%)

7.86 ± 1.07

Cerebral stroke

45 (6.9)

Fasting blood glucose (mg/dL)

159.2 ± 41.5

Angina pectoris

27 (4.1)

HOMA-IR

2.83 ± 1.80

Cardiac failure

11 (1.7)

HOMA-β (%)

32.1 ± 27.1

Myocardial infarction

18 (2.8)

C-peptide (ng/mL)

2.10 ± 0.89

Diet/exercise therapy

189 (29)

SBP (mm Hg)

130.9 ± 14.9

Low-dose glimepiride 0.5 - 1.0 mg

72 (11.1)

DBP (mm Hg)

76.5 ± 10.5

Medium-dose glimepiride 1.5 - 2.0 mg

50 (7.7)

Hypertension

393 (60.4)

Biguanide

99 (15.2)

Dyslipidemia

417 (64.1)

Thiazolidine

38 (5.8)

Hyperuricemia

65 (10)

α-GI

18 (2.8)

Retinopathy

48 (7.4)

Multiple-drug co-administration

185 (28.4)

**Table 2.** Single and Multiple Regression Analyses of Change in eGFR From Baseline to 3 Months
Independent variables	Single regression analysis	Multiple regression analysis
T2DM: type 2 diabetes mellitus; ARB: angiotensin II receptor blocker; ACEI: angiotensin converting enzyme inhibitor; HbA1c: glycated hemoglobin; M: month; eGFR: estimated glomerular filtration rate; Δ: change in; UACR: urinary albumin-to-creatinine ratio. ^‡P < 0.05 single regression analysis. ^§P < 0.05 multiple regression analysis.
Age	-0.008	-0.072	0.056	0.802
Sex (male)	0.682	-0.915	2.279	0.402
Duration of T2DM	-0.003	-0.012	0.006	0.512
Anti-hypertensive	-1.017	-2.524	0.490	0.185	-1.519	-3.545	0.506	0.141
With ARB or ACEI	-0.615	-2.132	0.901	0.426
HbA1c_0M	-0.358	-1.072	0.356	0.325
eGFR_0M	-0.135	-0.174	-0.097	> 0.001^‡	-0.130	-0.189	-0.072	> 0.001^§
SBP_0M	-0.016	-0.067	0.035	0.539
ΔHbA1c_3M	1.215	0.278	2.153	0.011^‡	0.867	-0.518	2.251	0.218
ΔSBP_3M	-0.035	-0.086	0.016	0.182	-0.024	-0.094	0.046	0.506
ΔUACR_3M	0.005	> 0.001	0.011	0.046^‡	0.005	0.000	0.010	0.040^§

Table 2. Single and Multiple Regression Analyses of Change in eGFR From Baseline to 3 Months

Independent variables

Single regression analysis

Multiple regression analysis

Regression coefficient

Lower limit

Upper limit

P-value

Partial regression coefficient

Lower limit

Upper limit

P-value

T2DM: type 2 diabetes mellitus; ARB: angiotensin II receptor blocker; ACEI: angiotensin converting enzyme inhibitor; HbA1c: glycated hemoglobin; M: month; eGFR: estimated glomerular filtration rate; Δ: change in; UACR: urinary albumin-to-creatinine ratio. ^‡P < 0.05 single regression analysis. ^§P < 0.05 multiple regression analysis.

Age

-0.008

-0.072

0.056

0.802

Sex (male)

0.682

-0.915

2.279

0.402

Duration of T2DM

-0.003

-0.012

0.006

0.512

Anti-hypertensive

-1.017

-2.524

0.490

0.185

-1.519

-3.545

0.506

0.141

With ARB or ACEI

-0.615

-2.132

0.901

0.426

HbA1c_0M

-0.358

-1.072

0.356

0.325

eGFR_0M

-0.135

-0.174

-0.097

> 0.001^‡

-0.130

-0.189

-0.072

> 0.001^§

SBP_0M

-0.016

-0.067

0.035

0.539

ΔHbA1c_3M

1.215

0.278

2.153

0.011^‡

0.867

-0.518

2.251

0.218

ΔSBP_3M

-0.035

-0.086

0.016

0.182

-0.024

-0.094

0.046

0.506

ΔUACR_3M

0.005

> 0.001

0.011

0.046^‡

0.005

0.000

0.010

0.040^§