An Observational Study to Evaluate Effect of Vildagliptin in Combination with Metformin and Glimepiride on Glycaemic Control and lipid profile in ...
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International Journal of Research and Review
Vol.8; Issue: 3; March 2021
Website: www.ijrrjournal.com
Original Research Article E-ISSN: 2349-9788; P-ISSN: 2454-2237
An Observational Study to Evaluate Effect of
Vildagliptin in Combination with Metformin and
Glimepiride on Glycaemic Control and lipid profile
in T2DM Patients
Dipti Ranjan Darjee
Asst. Professor, Dept. of Medicine, SCB Medical College, Cuttack
ABSTRACT Keywords: Vildagliptin, glimepiride, metformin,
T2DM.
Objective: The study was conducted to evaluate
the effect of addition of Vildagliptin in patients INTRODUCTION
on glycaemic control (Plasma glucose and The prevalence of diabetes in India
HbA1c) and Lipid Profile [Triglyceride (TG), is on the rise and is related to changing
Total cholesterol (TC), Low density lipoprotein characteristics of our population [1].
cholesterol (LDL-C), High density lipoprotein
Although diabetes is traditionally
cholesterol (HDL-C)] who were inadequately
control with glimepiride and metformin therapy. considered a metabolic disorder, it is now
Material and Method: This was a prospective viewed by many as a vascular disease as
observational study and patients who were not well [2]. This is based on the fact that most
adequately control with metformin and patients who have diabetes develop
glimepiride were included in this study. Patients cardiovascular (CV) complications, which
who were having HbA1c > 8% and comparably account for the majority of deaths in
higher lipid profile were included in this study. diabetic patients. CV complications of
All serological test were performed from NABL diabetes are especially concerning not only
accelerated pathological laboratory. Efficacy because of the emerging epidemic of
was measured by the changes in glycemic diabetes but also because of the earlier onset
parameters and in lipid profile from baseline to
of coronary artery disease in individual who
12 weeks.
Result: At the end of 12 weeks there were have diabetes [3-5]. Furthermore, the progress
statistical significant drop in glycemic of vascular disease in diabetes often begins
parameters i.e., fasting plasma glucose (pDipti Ranjan Darjee. An observational study to evaluate effect of vildagliptin in combination with metformin
and glimepiride on glycaemic control and lipid profile in T2DM patients.
Vildagliptin is a dipeptidyl performed from NABL accelerated
peptidase-4 (DPP-4) inhibitor that enhances pathological laboratory. Efficacy was
incretin hormone activity, sustains insulin measured by the changes in glycemic
levels, and reduces glycemia in type 2 parameters and in lipid profile from baseline
diabetes mellitus (T2DM) [10,11]. Several to 12 weeks.
previous clinical trials have shown that Unpaired ‘t‘ test for difference
vildagliptin monotherapy and add-on between two means were used to analyse
therapy are tolerable and effective in continuous variables at baseline and ’z’ test
patients with poor glycemic control [12-16]. for difference between two proportions were
The study was conducted to evaluate used to analyse categorical characteristics at
the effect of addition of Vildagliptin in baseline. Statistical software was used to
patients on glycaemic control (Plasma perform all statistical measurements. In
glucose and HbA1c) and Lipid Profile analysis, ‘p’ value < 0.05 was considered
[Triglyceride (TG), Total cholesterol (TC), statistically significant.
Low density lipoprotein cholesterol (LDL-
C), High density lipoprotein cholesterol RESULT
(HDL-C)] who were inadequately control Total 100 patients were participated
with glimepiride and metformin therapy. in this observational trial and the baseline
characteristics of the study populations were
MATERIAL AND METHOD listed in the following tables (Table 1). It
This was a prospective observational was observed that participants were having
study and patients who were not adequately long duration of diabetes (5.79 ± 2.32) and
control with metformin and glimepiride high BMI (25.82 ± 3.51) index. Glycemic
were included in this study. This was a parameters and lipid profiles were also
single centred study. listed in table 1.
Type 2 diabetes mellitus (T2DM) Table 1: Baseline characteristics of the study population
patients who were having HbA1c > 8% and Variables Total Participants (N=100)
comparably higher lipid profile were Age (Yrs.) 53.46 ± 7.10
Male (%) 58 (58%)
included in this study. Patients who were Duration of Diabetes (Yrs) 5.79 ± 2.32
having any abnormalities like history of any Weight (kgs.) 71.78 ± 7.23
BMI (kg/m 2) 25.82 ± 3.51
cardiovascular events, history of any type of FBS (mg/dl) 172.6 ± 17.34
micro or macro vascular complication, PPBS (mg/dl 261 ± 24.26
vision disability or with any serious adverse HbA1C (%) 9.66 ± 0.96
Total cholesterol (mg/dl) 188.34 ± 23.54
events were excluded from the study. TG (mg/dl) 171.95 ± 15.41
Baseline parameters such as LDL-C (mg/dl) 121.93 ± 16.1
Glycosylated haemoglobin (HbA1c), HDL-C (mg/dl) 41.21 ± 4.94
Postprandial Blood Sugar (PPBS), Fasting At the end of 12 weeks there were
Blood Sugar (FBS), Low Density statistical significant drop in glycemic
Lipoprotein–Cholesterol (LDL-C), parameters i.e., fasting plasma glucose
Triglycerides (TGs), Total–Cholesterol (p0.05) and glycated haemoglobin
(HDL-C) were assessed at the time of (HbA1c%) (pDipti Ranjan Darjee. An observational study to evaluate effect of vildagliptin in combination with metformin
and glimepiride on glycaemic control and lipid profile in T2DM patients.
There also a significant change risk factors for coronary atherosclerosis.
observed in lipid profile but there was not The presence of diabetes in an individual
significant increase in High density increases the risk of any procedure and is
lipoprotein cholesterol (HDL-C). associated with proper prognosis compared
Hypoglycaemic events were significantly to those individuals who do not have
low as compare to baseline. diabetes.
The combination of hyperglycemia,
hypertension, obesity, dyslipidemia and
At Baseline At 24th Week
atherosclerosis that is seen commonly with
20 diabetes mellitus increases the risk of
systolic and diastolic left ventricular (LV)
15 dysfunction and often leads to heart failure
Value Axis
in diabetic patients; this explains the more
10 common occurrence of the syndrome in
diabetic patients [21-24]. In this study At the
5 end of 12 weeks there were statistical
significant drop in glycemic parameters i.e.,
0
fasting plasma glucose (pDipti Ranjan Darjee. An observational study to evaluate effect of vildagliptin in combination with metformin
and glimepiride on glycaemic control and lipid profile in T2DM patients.
DPP4i like Vildagliptin. 10. AhrénB, Landin-OlssonM, JanssonPA, et al.
Inhibition of dipeptidyl peptidase-4 reduces
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Vol.8; Issue: 3; March 2021Dipti Ranjan Darjee. An observational study to evaluate effect of vildagliptin in combination with metformin
and glimepiride on glycaemic control and lipid profile in T2DM patients.
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