OBSERVATIONS

The present study on efficacy and safety of addition of

vildagliptin (dpp-4 inhibitor) to ongoing treatment with triple
drug therapy (metformin, glimipride and pioglitazone) in poorly
controlled type 2 diabetes mellitus consists of 30 patients of
type-2 Diabetes Mellitus attending OPD/admitted in Dept of
Medicine, Rajindra Hospital, Patiala.
All the patients and their relatives were informed about the
trial in their vernacular language. Written consent was taken. A
detailed history of each patient along with complete clinical
examination was carried out. After doing routine investigation as
enumerated in the proforma FBS, HbA1c, Liver function tests
and Lipid profile was done.
30 patients were started on Vildagliptin on low dose 50 mg
OD. Patients were followed every 2 weeks for their FBS levels and
if required dose of Vildagliptin was increased to 100 mg OD after
4 weeks. The study was conducted over period of 12 weeks and
at the end 12 weeks HbA1c was repeated along with FBS, Liver
function tests and Lipid profile. A detailed statistical analysis
was carried out and FBS levels were on week 0, 2, 4, 6, 8, 10
46

and 12 were compared statistically. Similarly, Lipid profile, HbA 1c

and Liver function tests were compared at 0 and end of 12
weeks.
STATISTICAL APPLIED
1. Arithmetic mean or average

Where

represents the arithmetic mean or average, X stands

for the sum of all the observations and N for the number of
observations.
2. Standard Deviation

Where a stands for standard deviation and for deviation of the

observation from the arithmetic mean.
N for the number of observations and X represents the
arithmetic mean or average X stands for the sum of all the
observations.
3. t test (Test of significance)
47

Where t stands for significance ratio with reference to t

distribution.
stands for arithmetic mean of first sample.

stands for arithmetic mean of second sample.

S.E. stands for standard error.

We have taken the .05 level of significance. In other words,
if the probability of obtaining a deviation equal to or greater than
that observed as a result of random sampling as 5% or more, we
say that the difference is not significant and if it is less than 5%,
we say that the difference is significant.

48

Sex-wise Distribution of cases

Sex
Male
Female
Total

Number of cases
11
19
30

%age
36.70%
63.30%
100.00%

As shown in the table above, out of the total 30 patients

studied 11, (36.7%) were male and 19(63.30%) were female.

49

Socio-Economic Status wise Distribution of cases

Socio Economic Status

Lower
Middle
Total

Number of cases
11
19
30

%age
36.70%
63.30%
100.00%

Out of total 30 patients studied 19 (63.30%) were from

middle socio-economic class and 11 (36.70%) were lower socioeconomic class.

50

Showing Mean values of other characteristics

Age (years)
Hb (gm%)
TLC
Neutrophils
Lymphocytes
Basophils
Eosinophils

Mean
53.87
10.93
6423.33
60.00
37.47
1.67
0.87

Standard Deviation
9.453
1.413
944.561
4.503
4.175
0.711
0.507

The mean age of the patients under the study was 53.87
years with standard deviation of 9.453 years. Mean hemoglobin
was 10.93 gm% with standard deviation of 1.413. The mean TLC
of the patients under study was 6423 cells/cu mm.
51

Showing FBS at various time intervals (n = 30)

Time

FBS

Interval

Mean SD

Baseline

189.43

Change

Mean

from

%age

baseline

change

20.43
181.83

7.60

19.75
175.13

4.20
14.30

19.57
165.73

5.73
23.70

17.63
158.27

6.80
31.17

After 10

16.91
152.47

7.89
36.97

wks
After 12

17.92
146.67

6.97
42.77

wks

17.80

7.41

After 2 wks
After 4 wks
After 6 wks
After 8 wks

't' value

p value

4.01%

9.915

< 0.001*

7.55%

13.668

< 0.001*

12.51%

19.094

< 0.001*

16.45%

21.631

< 0.001*

19.52%

29.048

< 0.001*

22.58%

31.621

< 0.001*

* p < 0.001; Highly significant

As shown in the table above, the mean FBS before start of

treatment was 189.43 mg/dl, at end of 2 weeks was 181.83
mg/dl, at end of 4 weeks was 175.13 mg/dl, at end of 6 weeks
was 165.73 mg/dl, at end of 8 weeks was 158.27 mg/dl, at end
of 10 weeks was 152.47 mg/dl and at end of 12 weeks was

52

146.67 mg/dl. Thus, a steady decrease during the study can be

seen.
Showing HBA1C before treatment and after 12 weeks (n =30)

Time
Interval
Baseline

HbA1C

Change

Mean

Mean

from

%age

SD
8.686

baseline

change

After 12

1.178
7.860

0.826

wks

0.951

0.33

't' value

p value

9.51%

13.694

< 0.001*

* p < 0.001; Highly significant

As shown in the table above, the mean HbA1c before start of

treatment was 8.686% and after 12 weeks of study was 7.860%
showing significant change during the study.

53

Showing Triglycerides before treatment and after 12 weeks (n=30)

Time

TG

Interval

Mean SD

Baseline

164.70

Change

Mean

from

%age

baseline

change

0.769%

0.961

0.345NS

After 12

34.76
165.97

1.267

wks

31.26

7.22

't'
value

p value

NS: p > 0.05; Not Significant

As shown in the table above, the mean serum triglyceride

levels before the treatment were 164.70 mg/dl and after 12
weeks of study were 165.97 mg/dl showing no significant effect.

54

Showing LDL before treatment and after 12 weeks (n = 30)

Time

LDL

Interval

Mean SD

Baseline

116.90

Change

Mean

from

%age

baseline

change

After 12

31.62
118.10

1.20

wks

29.49

4.99

1.03%

't'

value

value

1.315

0.199N
S

NS: p > 0.05; Not Significant

As shown in the table above, the mean serum LDL levels

before start of treatment were 116.90 mg/dl and after 12 weeks
of study were 118.10 mg/dl. Thus, no significant effect was seen.

55

Showing HDL before treatment and after 12 weeks (n = 30)

Time

HDL

Interval

Mean SD

Baseline

38.47

Change

Mean

from

%age

baseline

change

After 12

3.88
38.40

0.067

wks

3.10

1.91

NS: p > 0.05; Not Significant

56

't'

value

value

0.17%

0.191

0.850NS

As shown in the table above, the mean serum HDL levels

were 38.47 mg/dl before start of treatment and 38.40 mg/dl
after 12 weeks of therapy. No significant effect was seen.

Showing Total Cholesterol before treatment and after 12

weeks (n = 30)

Time

TCh

Interval

Mean SD

Baseline

183.30

Change

Mean

from

%age

baseline

change

After 12

29.84
184.60

1.30

wks

27.77

6.84

NS: p > 0.05; Not Significant

57

0.71%

't'

value

value

1.041

0.306N
S

As shown in the table above, the mean serum total

cholesterol levels were 183.30 mg/dl before start of treatment
and 184.60 mg/dl after 12 weeks of therapy. No significant effect
was seen.

Showing Serum Creatinine before treatment and after 12

weeks (n = 30)

Time

S. Creat.

Interval

Mean SD

Baseline
After 12

0.987
0.141
1.043

Change

Mean

from

%age

baseline

change

0.057
58

't'

value

value

5.78%

1.543

0.134NS

wks

0.189

0.20

NS: p > 0.05; Not Significant

The mean serum creatinine before start of treatment was

0.987 mg/dl and after 12 weeks of treatment was 1.043. No
significant change was seen during the study.

Showing Blood Urea before treatment and after

12 weeks (n = 30)
Time

B. Urea

Change

Mean

't'

Interval

Mean SD

from

%age

value

value

59

Baseline

35.33

baseline

change

5.38%

1.686

0.103NS

After 12

5.28
33.43

1.90

wks

5.81

6.17

NS: p > 0.05; Not Significant

The mean blood urea before start of treatment was 35.33

mg/dl and at end of treatment was 33.43 mg/dl. No significant
change was seen.

60

Showing SGOT before treatment and after 12 weeks (n = 30)

Time

SGOT

Interval

Mean SD

Baseline

27.57

Change

Mean

from

%age

baseline

change

After 12

7.56
26.80

0.77

wks

4.92

4.77

't'

value

value

2.79%

0.881

0.386NS

NS: p > 0.05; Not Significant

As shown in the study, the mean SGOT levels before start

of treatment were 27.57 IU/L and after 12 weeks were 26.80
IU/L showing no significant effect.

61

Showing SGPT before treatment and after 12 weeks (n = 30)

Time

SGPT

Interval

Mean SD

Baseline

24.97

Change

Mean

from

%age

baseline

change

After 12

8.48
25.67

0.70

wks

5.96

4.55

2.80%

't'

value

value

0.843

0.406N
S

NS: p > 0.05; Not Significant

The mean SGPT levels before start of treatment were 24.97

IU/L and after 12 weeks were 25.67 IU/L showing no significant
effect.

62

Showing ALP before treatment and after 12 weeks (n = 30)

Time

ALP

Interval

Mean SD

Baseline

88.67

Change

Mean

from

%age

baseline

change

After 12

21.77
89.63

0.96

wks

20.52

12.27

1.08%

't'

value

value

0.431

0.669N
S

NS: p > 0.05; Not Significant

As shown in the table above, the mean ALP levels before

start of treatment were 88.67 IU/L and after 12 weeks were
89.63 IU/L showing no significant effect.

63

Showing Serum Bilirubin before treatment and after

12 weeks (n = 30)

Time

S. Bilirubin

Interval

Mean SD

Baseline

0.700

Change

Mean

from

%age

baseline

change

After 12

0.213
0.727

0.027

wks

0.202

0.17

NS: p > 0.05; Not Significant

64

't'

value

value

3.86%

0.859

0.397NS

As shown in the table above, the mean serum bilirubin

levels before start of treatment were 0.7 mg/dl and after 12
weeks were 0.727mg/dl showing no significant effect.

65