International Journal of Health and Clinical Research, 2020;3(4):128-133 e-ISSN: 2590-3241, p-ISSN: 2590-325X

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Original Research Article
Comparative study of change of HbA1c with voglibose and teneligliptin on ongoing
metformin monotherapy
Pratyay Pratim Datta1*, Ratneshwar Bhattacharya2, Sukanta Sen3, Chandra Narayan Gupta4
1
Block Medical Officer of Health, Kotshila Rural Hospital, Jaldah-II, Purulia, West Bengal 723213, India
2
Associate Professor, Department of General Medicine, ICARE Institute of Medical Sciences and Research,
Banbishnupur, Purba Medinipur, Haldia, West Bengal 721645, India
3
Professor & Head, Department of Pharmacology, ICARE Institute of Medical Sciences and Research,
Banbishnupur, Purba Medinipur, Haldia, West Bengal 721645, India
4
Associate Professor, Department of General Medicine, ICARE Institute of Medical Sciences and Research,
Banbishnupur, Purba Medinipur, Haldia, West Bengal 721645, India

Received: 28-06-2020 / Revised: 30-07-2020 / Accepted: 03-08-2020

Abstract
Background: Metformin is a biguanide used as first line treatment of type 2 diabetes mellitus. When Metformin
alone is unable to control glycaemic status properly then additional drug needs to be added. Some of the additional
drugs reduce primarily fasting blood sugar (FBS) and some reduce post prandial blood sugar (PPBS). Voglibose and
Teneligliptin are primarily capable of reducing PPBS. Overall hyperglycaemia is also controlled by these drugs. In
this background the present study was planned for comparative study of Voglibose and Teneligliptin to reduce
HbA1c ongoing Metformin monotherapy. Materials & Methods: It was a hospital based longitudinal interventional
study among patients attending General Medicine Outpatient Department (OPD) of a Medical College, East
Medinipur, West Bengal with uncontrolled hyperglycemia and whose HbA1c was above 7 but up to 10% and PPBS
above 200mg/dl. One group of patients was given voglibose 0.3mg TDS and another group of patients were given
teneligliptin 20mg BD in addition to previous dose of metformin. After 12 weeks of starting additional drug again
HbA1c level was assessed for each patient. Results: It was found that mean HbA1c level at the beginning was
8.89% for voglibose group and 8.83% for teneligliptin group. There was no significant difference between these
two. After 12 weeks of therapy the mean HbA1c level of voglibose group was significantly higher than teneligliptin
group. However both groups showed significant reduction of HbA1c as compared to starting. Conclusion: The
study highlights the ability to reduce HbA1c is more with teneligliptin 20mg BD than voglibose 0.3mg TDS.
Keywords: Type 2 Diabetes, glycosylated haemoglobin (HbA1c), fasting blood sugar (FBS), post prandial blood
sugar (PPBS), metformin, voglibose, teneligliptin.
This is an Open Access article that uses a fund-ing model which does not charge readers or their institutions for access and distributed under the
terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative
(http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the
original work is properly credited.

Introduction

Diabetes mellitus is now a days one of the most Type 2 diabetes mellitus is mainly caused by insulin
common non communicable disease in India. resistance and insulin deficiency. Due to impaired
Approximately 8.8% adults aged 20-79 years are action of insulin and lack of secretion of insulin there is
suffering from diabetes according to a study in 2017 imbalance d metabolism of glucose. Different
[1]. Diabetes mellitus has different types of entity of microvascular and macrovascular complications are
which commonest form is Type 2 diabetes mellitus. due to cellular damage from chronic hyperglycemia
__________________ resulting from impaired metabolism of glucose [2]. It
*Correspondence occurs usually at advanced age above the age of 40
Dr. Pratyay Pratim Datta years. However sometimes it can start at early age.
Block Medical Officer of Health, Kotshila Rural Different lifestyle factors have an impact on its
Hospital, Jaldah-II, PO- Jindaru, Purulia, West Bengal development like lack of physical exercise, eating fast
723213, India food, obesity etc. Treatment primarily consists of
E-mail: pratyaypratimdatta@gmail.com dietary modifications and physical exercise. But once

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these measures are unable to control blood sugar Considering 10% patients would be lost to follow up or
adequately then drug therapy is initiated. Most discontinue the drug due to different reason, total
commonly used drug is Metformin. Metformin is a required sample is 94*1.1=103.4. So, 104 patients were
biguanide group of drug. It is used as first line therapy included in the study.
of type 2 diabetes mellitus patients [3]. For type 2 Sample design
diabetes mellitus Metformin is the drug till it alone is About 52 patients were included in each arm:
able to keep glycaemic level within normal limit. voglibose-metformin combination therapy and
However with metformin only many patients with teneligliptin-metformin combination therapy. The
T2DM remain inadequately managed, which results in selection of patients in each arm was done by
progressively declining glycemic control [4]. When randomization using lottery method.
Metformin alone is not able to control blood glucose Study Technique
level properly then additional drug is to be added. The Patients were randomized in two groups. One group
use of additional drug must be judicial. It is dependent received teneligliptin 20mg twice daily in addition to
on the level of hyperglycaemia as well as its type. metformin and the other group received Voglibose
Hyperglycaemia may be baseline (fasting) or after 0.3mg thrice daily in addition to metformin. HbA1c
taking food (post-prandial) or both. Drug therapy for was assessed before introduction of additional drug and
treatment of fasting and post prandial hyperglycaemia 12 weeks after starting additional drug.
control is different and accordingly drug is chosen. Inclusion Criteria
Overall glycaemic control is monitored by testing level  Persons having inadequate glycaemic
of glycosylated haemoglobin (HbA1c). It should be control with HbA1c above 7% but below
below 7%. Alpha glucosidase inhibitor, dipeptidyl 10%
peptidase 4 (DPP 4 inhibitor) are some of the drugs  Persons on metformin monotherapy
which are mainly capable of reducing postprandial  Type 2 diabetes mellitus
blood sugar (PPBS). But they are also capable of  Ambulatory patients
reducing overall glycaemic level. So, HbA1c is  Patients having PPBS above 200mg/dl
reduced with these two. The present study was aimed  Patients who can be followed up
to find out the comparative ability to reduce Exclusion Criteria
glycosylated haemoglobin (HbA1c) with voglibose
 Type 1 Diabetes mellitus
(one alpha glucosidase inhibitors) and teneligliptin
 Isolated rise of fasting blood sugar (FBS)
(DPP 4 inhibitor).
Materials and Methods  Non ambulatory patients
Type of study  HbA1c above 10%
It was a hospital based interventional longitudinal Institutional ethics committee permission was taken
study. and written informed consent was signed from each
Study area participants. Statistical test done was unpaired t test.
All patients giving informed consent attending General Results
Medicine OPD of ICARE Institute of Medical Sciences It was a hospital based longitudinal interventional
and Research with diabetes and on Metformin study among patients attending General Medicine
monotherapy with uncontrolled hyperglycaemia were outpatient department (OPD) of a Medical College,
included in the study till the required sample size is East Medinipur, West Bengal with uncontrolled
achieved. hyperglycemia and whose HbA1c was above 7 but up
Sample size to 10% and PPBS above 200mg/dl. Table 1 shows
Percentage of patients requiring additional anti-diabetic demographic clinical and laboratory characteristics of
medication over Metformin monotherapy is 38% [5, 6]. study participants. It shows that there was no
So prevalence of use of additional drug in treating significant difference between the baseline
Type 2 DM (p) is 38%=0.38 characteristics of two groups considering their age, sex,
So, (1-0.38)=0.62 is the number of patients not presence of co-morbidities, fasting and post-prandial
requiring additional drug over metformin (q). blood sugar level (FBS and PPBS level). Figure 1
If we allow error of 10% (L) shows the mean level of glycosylated haemoglobin
So, using the formula (HbA1c) before starting additional drug. There were
4pq/L2= (4*0.38*0.62)/(0.1*0.1)=94 two study groups. Group 1 received voglibose and
So, required sample size is 94. group 2 received teneligliptin. Mean HbA1c level of
Group 1 was 8.89% and of Group 2 was 8.83%. There
was no significant difference between mean HbA1c
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level between these two groups. Figure 2 shows mean Figure 3 shows the change of level of HbA1c with
level of HbA1c12 weeks after starting additional drug. these two additional drugs by a line diagram. The
For Group 1 it was 7.4% and for Group 2 it was 6.6%. starting point is before adding additional drug and end
Now the difference between these two is statistically point is after 12 weeks of continuing additional drug. It
significant (p<0.05) which indicates that people was seen that with both drugs the level of HbA1c have
belonging to Group 1 were having significantly higher decreased. It was further noticed that the change of
level of HbA1c than people belonging to Group 2. So HbA1c with voglibose was less than change of HbA1c
after completion of 12 weeks therapy with additional with teneligliptin. This difference was also found to be
drug, people receiving teneligliptin had significant statistically significant with p<0.05. Statistical test
lower level of HbA1c than people receiving voglibose. done was unpaired t test.

Table 1: Demographic clinical and laboratory characteristics of study participants

Patients characteristics Voglibose group Teneligliptin group P value

Age
<60 years 36 39 >0.05
>60 years 16 13
Sex
Male 25 28 >0.05
Female 27 24
BMI 27.5±4.1kg/m2 27.1±4.4kg/m2 >0.05
FBS 198±25.8 mg/dl 199±27.4 mg/dl >0.05
PPBS 296±35.2 mg/dl 288±32.8 mg/dl >0.05
Presence of co-morbidities
Hypertension 17 (33%) 19 (37%)
Dyslipidaemia 14 (27%) 13 (25%)
CV events 4 (8%) 5 (10%)

10.00% 8.89% 8.83%

8.00%
6.00%
4.00%
2.00%
0.00%
Voglibose Teneligliptin

Figure 1: Mean level of HbA1c before starting additional drug

8.00% 7.40% 6.60%

6.00%
4.00%
2.00%
0.00%
Voglibose Teneligliptin

Figure 2: Mean level of HbA1c12 weeks after starting additional drug

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10.00%
9.00%
8.00%
7.00%
6.00%
5.00% Voglibose
4.00% Teneligliptin
3.00%
2.00%
1.00%
0.00%
Beginninng After 12 weeks
Figure 3: Change of mean HbA1c level with additional drug

Discussion Similarly another study by Matsushima Y et al

highlights superiority of sitagliptin over voglibose
Glycosylated haemoglobin (HbA1c) gives an overall [17].DPP-4 inhibitors work in a glucose dependent
picture of glycaemic control of past three months (12 manner, so they are able to lower HbA1c level
weeks). Target HbA1c should be within 7%. Recent significantly with minimum chance of hypoglycemic
studies suggest that very tight glycaemic control is episode. As a result after the introduction of sitagliptin
often not beneficial and sometimes detrimental for in 2006, the first DPP4 inhibitor, the use of DPP4
overall prognosis of a diabetic patient [7-9]. Rather inhibitors is increased remarkably. Mostly they are
HbA1c between 6.5% and 7% should be beneficial for used as add on therapy to metformin or sulfonylurea.
long term prognosis and preventing complications of Among all DPP4 inhibitors sitagliptin was first
diabetes. If HbA1c persists above 7% then that approved in 2006. Gradually more and more DPP4
indicates inadequate glycaemic control which is also inhibitors were developed [18]. But one of the major
detrimental and promotes different microvascular and restricting factors of their use is their cost. Due to high
macrovascular complications of diabetes. Tight cost of DPP4 inhibitors poor patients often are unable
glycaemic control is often required in different acute to continue these for long time. Unlike other DPP4
conditions including infection and sepsis [10-12]. So inhibitors teneligliptin has much lower cost. So in rural
maintenance of optimum level of HbA1c is essential India its use is popular considering its compliance
[13-14]. Drugs should be adjusted in such a way and among poor patients. Teneligliptin which is classified
such a combination so that HbA1c should persist as peptidomimetic has a unique structure having five
between 6.5% and 7%. consecutive rings [19]. So it acts on S2 extensive
Different studies have been conducted worldwide on subsite of DPP4 and this interaction increases its
comparative efficacy of different DPP4 inhibitors with potency and selectivity [20, 21]. Based on the results of
voglibose. However head to head study between a few head-to-head trials or meta-analyses comparing
teneligliptin and voglibose is very less. In a study the efficacy between DPP-4 inhibitors, there is general
conducted by Dabhi AS et al it was seen that with consensus that the HbA1c-lowering effects of gliptins
voglibose 0.2mg TDS dose mean change of HbA1c are broadly similar [22, 23].Voglibose belongs to class
was -0.38+- 0.04% as compared to -0.95 +- 0.04% in of comparative alpha glucosidase inhibitors which was
group treated with vildagliptin 50mg BD [15]. discovered in 1981 [24]. Voglibose causes reversible
Endpoint HbA1c of <6.5% was also achieved by much inhibition of membrane bound intestines alpha
lower percentage of patients in voglibose group than glucosidase which hydrolyze oligosaccharides and
Vildagliptin group (24% compared with 51%). Another disaccharides to glucose and other monosaccharides in
study by Iwamoto Y et al also finds superiority of the brush border of small intestine. So voglibose delays
vildagliptin over voglibose in reducing HbA1c [16]. the absorption and digestion of dietary polysaccharides
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by reversibly inhibiting carbohydrate digestive and cardiovascular effects in type 2 diabetic
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Source of Support:Nil
Conflict of Interest: Nil

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