J Endocrinol Metab

Journal of Endocrinology and Metabolism, ISSN 1923-2861 print, 1923-287X online, Open Access

Article copyright, the authors; Journal compilation copyright, J Endocrinol Metab and Elmer Press Inc

Journal website http://www.jofem.org

Original Article

Volume 10, Number 1, February 2020, pages 16-22

Control of Glycemia With a Basal-Plus Regimen in People With Type 2 Diabetes Mellitus Insufficiently Controlled by Previous Treatment

**Table 1.** Baseline Characteristics of the Study Participants
Variables	N	Mean ± SD	Range
N: number of subjects/available data; SD: standard deviation. Results were reported taking into account available data. Missing data were not counted in the total number of subjects or percentages.
Age (year)	848	59.0 ± 9.4	30 - 87
Gender	835
Female	444 (53.2%)	-	-
Male	391 (46.8%)	-	-
Height (cm)	846	167.2 ± 8.6	142 - 192
Weight (kg)	850	76.5 ± 11.8	43 - 117
Body mass index (kg/m²)	846	27.4 ± 4.0	16.7 - 50.0
Duration of diabetes (years)	853	10.8 ± 6.7	1 - 45
Heart rate (bpm)	823	77.3 ± 8.6	54 - 128
Systolic blood pressure (mm Hg)	844	133.4 ± 14.8	93 - 230
Diastolic blood pressure (mm Hg)	838	75.6 ± 9.7	50 - 120

Table 1. Baseline Characteristics of the Study Participants

Variables

Mean ± SD

Range

N: number of subjects/available data; SD: standard deviation. Results were reported taking into account available data. Missing data were not counted in the total number of subjects or percentages.

Age (year)

848

59.0 ± 9.4

30 - 87

Gender

835

Female

444 (53.2%)

Male

391 (46.8%)

Height (cm)

846

167.2 ± 8.6

142 - 192

Weight (kg)

850

76.5 ± 11.8

43 - 117

Body mass index (kg/m²)

846

27.4 ± 4.0

16.7 - 50.0

Duration of diabetes (years)

853

10.8 ± 6.7

1 - 45

Heart rate (bpm)

823

77.3 ± 8.6

54 - 128

Systolic blood pressure (mm Hg)

844

133.4 ± 14.8

93 - 230

Diastolic blood pressure (mm Hg)

838

75.6 ± 9.7

50 - 120

**Table 2.** Gla-100 and Glulisine Doses (Mean ± SD) Throughout the Study
	Baseline	12 weeks	24 weeks
SD: standard deviation; OD: once daily; BID: twice daily; TID: thrice daily. N: number of subjects/available data. Results were reported taking into account available data. Missing data were not counted in the total number of subjects or percentages.
Gla-100
OD	849	20.7 ± 8.5	837	22.7 ± 8.9	815	23.5 ± 9.0
BID	2	33.0 ± 9.9	3	28.0 ± 11.1	2	29.5 ± 9.2
Glulisine
OD	725	9.7 ± 4.2	659	10.7 ± 3.9	612	11.5 ± 4.9
BID	46	10.1 ± 4.4	120	14.4 ± 7.1	122	14.8 ± 6.9
TID	12	10.0 ± 4.5	26	15.6 ± 9.0	54	16.6 ± 10.3

Table 2. Gla-100 and Glulisine Doses (Mean ± SD) Throughout the Study

Baseline

12 weeks

24 weeks

Units/day

SD: standard deviation; OD: once daily; BID: twice daily; TID: thrice daily. N: number of subjects/available data. Results were reported taking into account available data. Missing data were not counted in the total number of subjects or percentages.

Gla-100

849

20.7 ± 8.5

837

22.7 ± 8.9

815

23.5 ± 9.0

BID

33.0 ± 9.9

28.0 ± 11.1

29.5 ± 9.2

Glulisine

725

9.7 ± 4.2

659

10.7 ± 3.9

612

11.5 ± 4.9

BID

10.1 ± 4.4

120

14.4 ± 7.1

122

14.8 ± 6.9

TID

10.0 ± 4.5

15.6 ± 9.0

16.6 ± 10.3

**Table 3.** Mean HbA1c Changes Throughout the Study and Percentage of Patients Achieving Target Values
	Baseline (n = 851)	12 weeks (n = 835)	24 weeks (n = 809)
All differences (means or percentages) between visits are significant (P < 0.001). Confidence intervals at 95% are presented between round brackets. HbA1c: hemoglobin A1c.
HbA1c (%)	9.50 ± 1.51	8.08 ± 1.06	7.37 ± 0.88
ΔHbA1c (%)	-	-1.42 (-1.53, -1.30)	-2.13 (-2.25, -2.02)
HbA1c < 7.0%	0%	10.2% (8.1, 12.2)	33.0% (29.7, 36.1)
HbA1c ≤ 6.5%	0%	3.5% (2.3, 4.8)	14.5% (12.0, 16.9)

Table 3. Mean HbA1c Changes Throughout the Study and Percentage of Patients Achieving Target Values

Baseline (n = 851)

12 weeks (n = 835)

24 weeks (n = 809)

All differences (means or percentages) between visits are significant (P < 0.001). Confidence intervals at 95% are presented between round brackets. HbA1c: hemoglobin A1c.

HbA1c (%)

9.50 ± 1.51

8.08 ± 1.06

7.37 ± 0.88

ΔHbA1c (%)

-1.42 (-1.53, -1.30)

-2.13 (-2.25, -2.02)

HbA1c < 7.0%

10.2% (8.1, 12.2)

33.0% (29.7, 36.1)

HbA1c ≤ 6.5%

3.5% (2.3, 4.8)

14.5% (12.0, 16.9)

**Table 4.** Mean FBG and PPBG Values Over the Course of the Study
	N	Baseline	N	12 weeks	N	24 weeks
N: number of subjects/available data. Results were reported taking into account available data. Missing data were not counted in the total number of subjects or percentages. FBG: fasting blood glucose; PPBG: postprandial blood glucose.
FBG (mg/dL)	810	198 ± 65	788	148 ± 40	769	129 ± 32
ΔFBG (mg/dL)	-	-	788	-57 (-79, -35)	769	-88 (-110, -66)
PPBG (mg/dL)	674	277 ± 72	678	200 ± 51	676	168 ± 41
ΔPPBG (mg/dL)	-	-	674	-78 (-84, -72)	674	-108 (-114, -102)

Table 4. Mean FBG and PPBG Values Over the Course of the Study

Baseline

12 weeks

24 weeks

N: number of subjects/available data. Results were reported taking into account available data. Missing data were not counted in the total number of subjects or percentages. FBG: fasting blood glucose; PPBG: postprandial blood glucose.

FBG (mg/dL)

810

198 ± 65

788

148 ± 40

769

129 ± 32

ΔFBG (mg/dL)

788

-57 (-79, -35)

769

-88 (-110, -66)

PPBG (mg/dL)

674

277 ± 72

678

200 ± 51

676

168 ± 41

ΔPPBG (mg/dL)

674

-78 (-84, -72)

674

-108 (-114, -102)

**Table 5.** Sub-Analysis of Glycemic Control in Participants According to Their Previous Type of Antidiabetic Treatment
Treatment	Baseline	12 weeks	24 weeks	P
FBG: fasting blood glucose; OAD: oral antihyperglycemic drugs; PPBG: postprandial blood glucose; HbA1c: hemoglobin A1c.
Basal insulin ± OADs (n = 470)
HbA1c < 7.0%	0%	9.2%	31.6%	-
HbA1c ≤ 6.5%	0%	3.0%	12.8%	-
HbA1c (%)	9.29 ± 1.40	8.06 ± 1.06	7.41 ± 0.90	< 0.001
FBG (mg/dL)	178 ± 63	140 ± 39	126 ± 32	< 0.001
PPBG (mg/dL)	264 ± 72	191 ± 48	163 ± 39	< 0.001
2 OADs (n = 272)
HbA1c < 7.0%	0%	13.3%	33.2%	-
HbA1c ≤ 6.5%	0%	5.5%	16.0%	-
HbA1c (%)	9.77 ± 1.51	8.06 ± 1.03	7.37 ± 0.85	< 0.001
FBG (mg/dL)	223 ± 62	158 ± 40	134 ± 33	< 0.001
PPBG (mg/dL)	293 ± 68	213 ± 52	175 ± 40	< 0.001
Premixed insulin ± OADs (n = 35)
HbA1c < 7.0%	0%	8.6%	51.4%	-
HbA1c ≤ 6.5%	0%	0.0%	31.4%	-
HbA1c (%)	9.13 ± 1.16	7.98 ± 0.93	6.98 ± 0.89	< 0.001
FBG (mg/dL)	199 ± 47	148 ± 34	122 ± 24	< 0.001
PPBG (mg/dL)	252 ± 55	193 ± 40	174 ± 50	< 0.001

Table 5. Sub-Analysis of Glycemic Control in Participants According to Their Previous Type of Antidiabetic Treatment

Treatment

Baseline

12 weeks

24 weeks

FBG: fasting blood glucose; OAD: oral antihyperglycemic drugs; PPBG: postprandial blood glucose; HbA1c: hemoglobin A1c.

Basal insulin ± OADs (n = 470)

HbA1c < 7.0%

9.2%

31.6%

HbA1c ≤ 6.5%

3.0%

12.8%

HbA1c (%)

9.29 ± 1.40

8.06 ± 1.06

7.41 ± 0.90

< 0.001

FBG (mg/dL)

178 ± 63

140 ± 39

126 ± 32

< 0.001

PPBG (mg/dL)

264 ± 72

191 ± 48

163 ± 39

< 0.001

2 OADs (n = 272)

HbA1c < 7.0%

13.3%

33.2%

HbA1c ≤ 6.5%

5.5%

16.0%

HbA1c (%)

9.77 ± 1.51

8.06 ± 1.03

7.37 ± 0.85

< 0.001

FBG (mg/dL)

223 ± 62

158 ± 40

134 ± 33

< 0.001

PPBG (mg/dL)

293 ± 68

213 ± 52

175 ± 40

< 0.001

Premixed insulin ± OADs (n = 35)

HbA1c < 7.0%

8.6%

51.4%

HbA1c ≤ 6.5%

0.0%

31.4%

HbA1c (%)

9.13 ± 1.16

7.98 ± 0.93

6.98 ± 0.89

< 0.001

FBG (mg/dL)

199 ± 47

148 ± 34

122 ± 24

< 0.001

PPBG (mg/dL)

252 ± 55

193 ± 40

174 ± 50

< 0.001