Efficacy of a Combination of Metformin and Vildagliptin in Comparison to Metformin Alone in Type 2 Diabetes Mellitus: A Multicentre, Retrospective, Real-World Evidence Study

Figures & data

Table 1 Baseline Characteristics of Treatment Arms

Baseline Variables		Metformin (N= 2452)	Metformin + Vildagliptin (N= 288)	p
Gender
Female, N (%)		978 (39.9%)	92 (31.9%)	0.009
Male, N (%)		1474 (60.1%)	196 (68.1%)
Age (years), Mean (SD)		49.2 (9.4)	48.3 (10.5)	0.119
BMI (kg/m^2), Mean (SD)		28.2 (4.2)	28.5 (4.5)	0.291
SBP (mmHg), Mean (SD)		127.9 (15.8)	128.8 (17.5)	0.346
DBP (mmHg), Mean (SD)		81.5 (8.6)	82.1 (9.5)	0.225
Weight (in kg), Mean (SD)		74.5 (12.8)	77.5 (14.0)	<0.001
Triglyceride levels, Mean (SD)		162.9 (102.6)	158.8 (98.9)	0.541
Age at onset of T2DM (years), Mean (SD)		46.3 (9.3)	46.3 (10.2)	0.968
Duration of T2DM (years), Mean (SD)		2.9 (1.2)	1.7 (1.7)	<0.001
Baseline HbA1c levels (%), Mean (SD)		7.1 (0.9)	8.1 (1.6)	<0.001
HbA1c <7%	N (%)	1268 (51.7%)	71 (76.3%)	<0.001
	Mean (SD)	6.4 (0.4)	6.4 (0.3)	0.781
HbA1c ≤7.5%	N (%)	1907 (77.8%)	124 (43.1%)	<0.001
	Mean (SD)	6.7 (0.5)	6.8 (0.5)	0.062
HbA1c >7.5%	N (%)	545 (22.2%)	164 (56.9%)	<0.00001
	Mean (SD)	8.4 (1.0)	9.1 (1.4)	<0.00001
HbA1c >9%	N (%)	92 (3.8%)	67 (23.3%)	<0.001
	Mean (SD)	10.1 (1.2)	10.5 (1.2)	0.07

Note: Level of significance was considered to be p<0.05.

Abbreviations: SD, standard deviation; BMI, body mass index; SBP, systolic blood pressure; DBP, diastolic blood pressure; T2DM, type 2 diabetes mellitus; HbA1c, glycosylated hemoglobin.

Table 2 Treatment Details and HbA1c Levels at Follow Up Visit

Categories	Metformin (N= 2452)	Metformin + Vildagliptin (N= 288)	p
Post-treatment HbA1c levels over similar duration of follow-up (%)
HbA1c <7%, N (%)	1184 (48.3%)	141 (49.0%)	0.829
HbA1c ≤7.5%, N (%)	1623 (66.2%)	195 (67.7%)	0.606
HbA1c >7.5%, N (%)	522 (21.3%)	93 (32.3%)	<0.0001
HbA1c level at the follow-up visit (%)
Mean (SD)	7.2 (1.3)	7.4 (1.5)	0.014
Change in HbA1c level from baseline to follow-up (%)
Overall Median (Range)	0 (17.6)	−0.5 (13.2)	<0.001
Gender wise change in HbA1c level from baseline to follow-up (%)
Male Median (Range)	0 (14.9)	−0.6 (13.2)	<0.001
Female Median (Range)	0 (12.1)	−0.5 (10.6)	<0.001
Patients requiring add-on drug
N (%)	863 (35.2%)	45 (15.6%)	<0.001
Duration for add-on drug requirement (Months)
Mean (SD)	14.3 (9.2)	10.4 (8.1)	0.005

Note: Level of significance was considered to be p<0.05.

Abbreviations: HbA1c, glycosylated hemoglobin; SD, standard deviation.

Table 3 Change in HbA1c Levels by Different Baseline and Follow-Up HbA1c Level Categories

Baseline HbA1c Levels (%)	Follow-up HbA1c Levels (%)	Metformin	Metformin + Vildagliptin	p
		Patient Count N (%)	Patient Count N (%)
≤7.5%	≤7.5%	1534 (80.4%)	106 (85.5%)	0.292
	>7.5%–≤9%	263 (13.8%)	11 (8.8%)
	>9%	110 (5.7%)	7 (5.6%)
>9%	≤7.5%	26 (28.3%)	37 (55.2%)	0.002
	>7.5%–≤9%	34 (36.9%)	14 (20.9%)
	>9%	32 (34.8%)	16 (23.9%)

Note: Level of significance was considered to be p<0.05.

Abbreviation: HbA1c, glycosylated hemoglobin.

Table 4 Adverse Events by Treatment Group

Adverse Events	Metformin (N=810) n (%)	Metformin + Vildagliptin (N=97) n (%)	p
Giddiness	150 (18.5%)	13 (13.3%)	0.215
Fatigue	110 (13.6%)	15 (15.5%)	0.611
Gastric discomfort	33 (4.1%)	4 (4.1%)	0.47
Constipation	18 (2.2%)	0 (0%)	–
Bloating	5 (0.6%)	0 (0%)	–
Hypoglycemia	2 (0.2%)	0 (0%)	–

Note: Level of significance was considered to be p<0.05.