Table 2. Open in new tab Effect of...

Parameters	Change After 12 Wk	P Value
Average glucose (CGM)
mmol/L	0.04 ± 0	−0.83 ± 0.33	.07
mg/dL	3.1 ± 6	−15 ± 6
HbA1c, %	0 ± 0.2	−0.66 ± 0.08	<.01
mmol/mmol	0 ± 2.2	−7.2 ± 0.9
Fasting glucose (CGM)
mmol/L	0.27 ± 0.83	−0.72 ± 0.61	.35
mg/dL	5 ± 15	−13 ± 11
Glucose SD (CGM)
mmol/L	−0.02 ± 0.04	−0.5 ± 0.27	.16
mg/dL	2 ± 6	−9 ± 5
Coefficient of variation, %	2 ± 3	2 ± 2	016
Total insulin dose, U	0.1 ± 2.4	−3.5 ± 1.9	.29
Basal insulin dose, U	1.9 ± 0.5	−0.72 ± 0.96	<.05
Bolus insulin dose, U	−1.8 ± 2.4	−2.8 ± 2.3	.79
Time spent at BG concentrations, %
CGM: mmol/L (mg/dL)
<3.05 mmol/L (55)	−0.1 ± 0.4	−1.5 ± 1.0	.15
3.05–3.88 mmol/L (55–70)	0.3 ± 0.4	0.4 ± 1.0	.52
3.8–8.8 mmol/L (70–160)	−1.4 ± 1.0	10 ± 4	.12
8.8–13.3 mmol/L (160–240)	−0.5 ± 2.1	−4.2 ± 3.7	.27
13.3–22.25 mmol/L (240–400)	−6.9 ± 4.5	−6 ± 2.5	.82
Episodes of hypoglycemia per total number of SMBG readings, incidence %
<3.05 mmol/L (55 mg/dL)	0/28 (0)	1/30 (3)	.53^a
3.05–3.88 mmol/L (55–70 mg/dL	1/28 (4)	2/30 (7)	.69^a
Patients with hypoglycemia per total number of patients, n
<3.05 mmol/L (55 mg/dL)	3/9	9/17	.74^a
3.05–3.88 mmol/L (55–70 mg/dL)	2/9	10/17	.44^a
Body weight, kg	0.7 ± 1.5	−1.9 ± 0.54^b	<.05
BMI, kg/m²	−0 ± 0.2	−1 ± 0.6^b	<.05
SBP, mm Hg	0 ± 4	0 ± 2	.91
DBP, mm Hg	−3 ± 3	3 ± 2	.15
Pulse rate	−6 ± 3	−6 ± 3	094
Lipid panel
Total cholesterol	−19 ± 5	11 ± 5	<.01
LDL	−15 ± 5	7 ± 4	<.01
HDL	−3 ± 5	2 ± 1	.82
Triglycerides	−2 ± 4	2 ± 8	.65
eGFR	0 ± 5	−7 ± 2	.21

Parameters

Change After 12 Wk

P Value

Placebo (n = 9)

Triple Therapy (n = 17)

Average glucose (CGM)

mmol/L

0.04 ± 0

−0.83 ± 0.33

.07

mg/dL

3.1 ± 6

−15 ± 6

HbA1c, %

0 ± 0.2

−0.66 ± 0.08

<.01

mmol/mmol

0 ± 2.2

−7.2 ± 0.9

Fasting glucose (CGM)

mmol/L

0.27 ± 0.83

−0.72 ± 0.61

.35

mg/dL

5 ± 15

−13 ± 11

Glucose SD (CGM)

mmol/L

−0.02 ± 0.04

−0.5 ± 0.27

.16

mg/dL

2 ± 6

−9 ± 5

Coefficient of variation, %

2 ± 3

2 ± 2

016

Total insulin dose, U

0.1 ± 2.4

−3.5 ± 1.9

.29

Basal insulin dose, U

1.9 ± 0.5

−0.72 ± 0.96

<.05

Bolus insulin dose, U

−1.8 ± 2.4

−2.8 ± 2.3

.79

Time spent at BG concentrations, %

CGM: mmol/L (mg/dL)

<3.05 mmol/L (55)

−0.1 ± 0.4

−1.5 ± 1.0

.15

3.05–3.88 mmol/L (55–70)

0.3 ± 0.4

0.4 ± 1.0

.52

3.8–8.8 mmol/L (70–160)

−1.4 ± 1.0

10 ± 4

.12

8.8–13.3 mmol/L (160–240)

−0.5 ± 2.1

−4.2 ± 3.7

.27

13.3–22.25 mmol/L (240–400)

−6.9 ± 4.5

−6 ± 2.5

.82

Episodes of hypoglycemia per total number of SMBG readings, incidence %

<3.05 mmol/L (55 mg/dL)

0/28 (0)

1/30 (3)

.53^a

3.05–3.88 mmol/L (55–70 mg/dL

1/28 (4)

2/30 (7)

.69^a

Patients with hypoglycemia per total number of patients, n

<3.05 mmol/L (55 mg/dL)

3/9

9/17

.74^a

3.05–3.88 mmol/L (55–70 mg/dL)

2/9

10/17

.44^a

Body weight, kg

0.7 ± 1.5

−1.9 ± 0.54^b

<.05

BMI, kg/m²

−0 ± 0.2

−1 ± 0.6^b

<.05

SBP, mm Hg

0 ± 4

0 ± 2

.91

DBP, mm Hg

−3 ± 3

3 ± 2

.15

Pulse rate

−6 ± 3

094

Lipid panel

Total cholesterol

−19 ± 5

11 ± 5

<.01

LDL

−15 ± 5

7 ± 4

<.01

HDL

−3 ± 5

2 ± 1

.82

Triglycerides

−2 ± 4

2 ± 8

.65

eGFR

0 ± 5

−7 ± 2

.21

Parameters	Change After 12 Wk	P Value
Average glucose (CGM)
mmol/L	0.04 ± 0	−0.83 ± 0.33	.07
mg/dL	3.1 ± 6	−15 ± 6
HbA1c, %	0 ± 0.2	−0.66 ± 0.08	<.01
mmol/mmol	0 ± 2.2	−7.2 ± 0.9
Fasting glucose (CGM)
mmol/L	0.27 ± 0.83	−0.72 ± 0.61	.35
mg/dL	5 ± 15	−13 ± 11
Glucose SD (CGM)
mmol/L	−0.02 ± 0.04	−0.5 ± 0.27	.16
mg/dL	2 ± 6	−9 ± 5
Coefficient of variation, %	2 ± 3	2 ± 2	016
Total insulin dose, U	0.1 ± 2.4	−3.5 ± 1.9	.29
Basal insulin dose, U	1.9 ± 0.5	−0.72 ± 0.96	<.05
Bolus insulin dose, U	−1.8 ± 2.4	−2.8 ± 2.3	.79
Time spent at BG concentrations, %
CGM: mmol/L (mg/dL)
<3.05 mmol/L (55)	−0.1 ± 0.4	−1.5 ± 1.0	.15
3.05–3.88 mmol/L (55–70)	0.3 ± 0.4	0.4 ± 1.0	.52
3.8–8.8 mmol/L (70–160)	−1.4 ± 1.0	10 ± 4	.12
8.8–13.3 mmol/L (160–240)	−0.5 ± 2.1	−4.2 ± 3.7	.27
13.3–22.25 mmol/L (240–400)	−6.9 ± 4.5	−6 ± 2.5	.82
Episodes of hypoglycemia per total number of SMBG readings, incidence %
<3.05 mmol/L (55 mg/dL)	0/28 (0)	1/30 (3)	.53^a
3.05–3.88 mmol/L (55–70 mg/dL	1/28 (4)	2/30 (7)	.69^a
Patients with hypoglycemia per total number of patients, n
<3.05 mmol/L (55 mg/dL)	3/9	9/17	.74^a
3.05–3.88 mmol/L (55–70 mg/dL)	2/9	10/17	.44^a
Body weight, kg	0.7 ± 1.5	−1.9 ± 0.54^b	<.05
BMI, kg/m²	−0 ± 0.2	−1 ± 0.6^b	<.05
SBP, mm Hg	0 ± 4	0 ± 2	.91
DBP, mm Hg	−3 ± 3	3 ± 2	.15
Pulse rate	−6 ± 3	−6 ± 3	094
Lipid panel
Total cholesterol	−19 ± 5	11 ± 5	<.01
LDL	−15 ± 5	7 ± 4	<.01
HDL	−3 ± 5	2 ± 1	.82
Triglycerides	−2 ± 4	2 ± 8	.65
eGFR	0 ± 5	−7 ± 2	.21

Table 2.

Open in new tab

Effect of Triple Therapy (Dapagliflozin Plus Liraglutide and Insulin Treatment) on Glycemic Control, Body Weight, Insulin Dose, BP, Lipid Profile, and eGFR

Parameters	Change After 12 Wk		P Value
Parameters	Placebo (n = 9)	Triple Therapy (n = 17)	P Value
Average glucose (CGM)
mmol/L	0.04 ± 0	−0.83 ± 0.33	.07
mg/dL	3.1 ± 6	−15 ± 6
HbA1c, %	0 ± 0.2	−0.66 ± 0.08	<.01
mmol/mmol	0 ± 2.2	−7.2 ± 0.9
Fasting glucose (CGM)
mmol/L	0.27 ± 0.83	−0.72 ± 0.61	.35
mg/dL	5 ± 15	−13 ± 11
Glucose SD (CGM)
mmol/L	−0.02 ± 0.04	−0.5 ± 0.27	.16
mg/dL	2 ± 6	−9 ± 5
Coefficient of variation, %	2 ± 3	2 ± 2	016
Total insulin dose, U	0.1 ± 2.4	−3.5 ± 1.9	.29
Basal insulin dose, U	1.9 ± 0.5	−0.72 ± 0.96	<.05
Bolus insulin dose, U	−1.8 ± 2.4	−2.8 ± 2.3	.79
Time spent at BG concentrations, %
CGM: mmol/L (mg/dL)
<3.05 mmol/L (55)	−0.1 ± 0.4	−1.5 ± 1.0	.15
3.05–3.88 mmol/L (55–70)	0.3 ± 0.4	0.4 ± 1.0	.52
3.8–8.8 mmol/L (70–160)	−1.4 ± 1.0	10 ± 4	.12
8.8–13.3 mmol/L (160–240)	−0.5 ± 2.1	−4.2 ± 3.7	.27
13.3–22.25 mmol/L (240–400)	−6.9 ± 4.5	−6 ± 2.5	.82
Episodes of hypoglycemia per total number of SMBG readings, incidence %
<3.05 mmol/L (55 mg/dL)	0/28 (0)	1/30 (3)	.53^a
3.05–3.88 mmol/L (55–70 mg/dL	1/28 (4)	2/30 (7)	.69^a
Patients with hypoglycemia per total number of patients, n
<3.05 mmol/L (55 mg/dL)	3/9	9/17	.74^a
3.05–3.88 mmol/L (55–70 mg/dL)	2/9	10/17	.44^a
Body weight, kg	0.7 ± 1.5	−1.9 ± 0.54^b	<.05
BMI, kg/m²	−0 ± 0.2	−1 ± 0.6^b	<.05
SBP, mm Hg	0 ± 4	0 ± 2	.91
DBP, mm Hg	−3 ± 3	3 ± 2	.15
Pulse rate	−6 ± 3	−6 ± 3	094
Lipid panel
Total cholesterol	−19 ± 5	11 ± 5	<.01
LDL	−15 ± 5	7 ± 4	<.01
HDL	−3 ± 5	2 ± 1	.82
Triglycerides	−2 ± 4	2 ± 8	.65
eGFR	0 ± 5	−7 ± 2	.21

Parameters	Change After 12 Wk		P Value
Parameters	Placebo (n = 9)	Triple Therapy (n = 17)	P Value
Average glucose (CGM)
mmol/L	0.04 ± 0	−0.83 ± 0.33	.07
mg/dL	3.1 ± 6	−15 ± 6
HbA1c, %	0 ± 0.2	−0.66 ± 0.08	<.01
mmol/mmol	0 ± 2.2	−7.2 ± 0.9
Fasting glucose (CGM)
mmol/L	0.27 ± 0.83	−0.72 ± 0.61	.35
mg/dL	5 ± 15	−13 ± 11
Glucose SD (CGM)
mmol/L	−0.02 ± 0.04	−0.5 ± 0.27	.16
mg/dL	2 ± 6	−9 ± 5
Coefficient of variation, %	2 ± 3	2 ± 2	016
Total insulin dose, U	0.1 ± 2.4	−3.5 ± 1.9	.29
Basal insulin dose, U	1.9 ± 0.5	−0.72 ± 0.96	<.05
Bolus insulin dose, U	−1.8 ± 2.4	−2.8 ± 2.3	.79
Time spent at BG concentrations, %
CGM: mmol/L (mg/dL)
<3.05 mmol/L (55)	−0.1 ± 0.4	−1.5 ± 1.0	.15
3.05–3.88 mmol/L (55–70)	0.3 ± 0.4	0.4 ± 1.0	.52
3.8–8.8 mmol/L (70–160)	−1.4 ± 1.0	10 ± 4	.12
8.8–13.3 mmol/L (160–240)	−0.5 ± 2.1	−4.2 ± 3.7	.27
13.3–22.25 mmol/L (240–400)	−6.9 ± 4.5	−6 ± 2.5	.82
Episodes of hypoglycemia per total number of SMBG readings, incidence %
<3.05 mmol/L (55 mg/dL)	0/28 (0)	1/30 (3)	.53^a
3.05–3.88 mmol/L (55–70 mg/dL	1/28 (4)	2/30 (7)	.69^a
Patients with hypoglycemia per total number of patients, n
<3.05 mmol/L (55 mg/dL)	3/9	9/17	.74^a
3.05–3.88 mmol/L (55–70 mg/dL)	2/9	10/17	.44^a
Body weight, kg	0.7 ± 1.5	−1.9 ± 0.54^b	<.05
BMI, kg/m²	−0 ± 0.2	−1 ± 0.6^b	<.05
SBP, mm Hg	0 ± 4	0 ± 2	.91
DBP, mm Hg	−3 ± 3	3 ± 2	.15
Pulse rate	−6 ± 3	−6 ± 3	094
Lipid panel
Total cholesterol	−19 ± 5	11 ± 5	<.01
LDL	−15 ± 5	7 ± 4	<.01
HDL	−3 ± 5	2 ± 1	.82
Triglycerides	−2 ± 4	2 ± 8	.65
eGFR	0 ± 5	−7 ± 2	.21

Abbreviations: DBP, Diastolic BP; eGFR, estimated glomerular filtration rate; HDL, high-density lipoprotein; SBP, Systolic BP. Data are presented as mean ± SE. All P values are comparing change in triple therapy group vs placebo.

Fisher's exact t test.

P < .05 for change compared with baseline within group (paired t test).

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