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Vol 1 | Issue 2 | Jul - Sep 2022                                                                                        Indian J Pharm Drug Studies | 63  

Original Article 

A Comparitive Study on Efficacy and Safety of Vildagliptin-Metformin versus 

Glimepiride - Metformin in Type 2 Diabetes Mellitus Patients  

Prathap Bingi1, Shaik Kareemulla2, B. Himabindu3, D. Sheklane Khan3, G. Ramu3, S. Mahammed Rafi3  

From, 1Assistant Professor (GGH-RIMS), Kadapa, 2Associate Professor, 3PharmD Intern, Department of Pharmacy Practice, P. Rami 

Reddy Pharmacy College, Kadapa Andhra Pradesh.  

Correspondence to: Shaik Kareemulla, Associate Professor, Department of Pharmacy Practice, P. Rami Reddy Memorial College of 

Pharmacy (PRRMCP), Kadapa, Andhra Pradesh, Email: tanveerkareems@gmail.com  

ABSTRACT 

Background: Inadequate control of blood glucose in patients leads to micro or macrovascular complications. Metformin is an initial 

drug used to treat diabetes. In case of inefficient glucose control with Metformin, add-on therapy is recommended. The motto of our 

study is to compare the efficacy and safety of Vildagliptin-Metformin with Glimepiride – Metformin in type 2 diabetes. Aim & 

Objectives: This study was aimed to compare the efficacy and safety of Vildagliptin-Metformin with Glimepiride Metformin for 

patients with type 2 diabetes mellitus at Government General Hospital (GGH-RIMS), Kadapa. Objective: To assess the prognosis 

report, and compare the effectiveness and safety profiles of Group I (VildagliptinMetformin) patients with Group II (Glimepiride-

Metformin) patients and counsel them about a multi-disciplinary treatment approach by prov iding patient information leaflets to exhibit 

a better life. Methodology: A single-center prospective observational study was conducted for 6 months in the general medicine 

department at a government general hospital, in India. A total of 100 patients were recruited for this study and divided into 2 groups of 

50 patients each. Vildagliptin-Metformin group 1 and Glimepiride-Metformin group 2. Results: Glycated hemoglobin (HbA1C), fasting 

blood sugar levels (FBS), and random blood sugar levels (RBS) parameters are taken as primary and secondary endpoints to compare 

groups as per efficacy. In terms of safety weight gain, hypoglycemia, and other gastrointestinal adverse effects are considered. The 

difference between values of baseline and final followup of HbA1C, FBS, RBS is 0.50%, 20mg/dl, 85mg/dl in group 1 (V-M); whereas 

0.35%, 15mg/dl, 55mg/dl in group 2 (GM) respectively. 24 ADRs with respect to hypoglycemia, weight gain, abdominal pain, muscle 

tenderness, and diarrhea are observed in group 1 (VM) group and 46 ADRs are observed in group 2 (G-M). Conclusion: Vildagliptin-

metformin treatment provided favorable glucose control comparable to that of glimepiride-metformin treatment. It also resulted in better 

adverse event profiles with lower ris ks of hypoglycemia and weight gain. 

Key words: Type 2 diabetes, Metformin, Vildagliptin, Glimepiride, HbA1C, ADR’s 

ccording to an IDF report published in 2013, the global 

prevalence of diabetes in adults (20-79 years old) was 

8.3% (382 million people), with 14 million more males 

than females (198 million males vs 184 million females). This 

disease majorly occurs between 40 to 59 years of age and the 

number will rise beyond 592 million by 2035 with a 10.1% 

global prevalence [1]. The ADA has developed and provided 

diabetes care guidelines and related documents since 1989. Its 

clinical practice guidelines are integral resources for all health 

care professionals. According to ADA, Metformin is the 

preferred initial pharmacological agent for the treatment of 

T2DM. If Metformin is not tolerated, other options for first-line 

therapy include Sulfonylureas, Dipeptidyl peptidase 4 inhibitor 

(DPP-4i), and Sodium-Glucose linked transporter 2 inhibitor 

(SGLT2i), alpha-glucosidase inhibitors [2].  

Some studies documented that long-term vildagliptin 

combination therapy is safe and effective in Japanese T2DM 

patients [3]. Sanjay et al. concluded that saxagliptin in 

combination with metformin was generally well-tolerated in 

Indian T2DM patients [4]. Studies by Zang et al. concluded that 

compared with dual OAD non-vildagliptin combination 

therapies, vildagliptin add-on to metformin is effective and safe 

to achieve glycaemic control in Chinese patients with T2DM 

[5]. Harika et al. concluded that vildagliptin and metformin 

combination provided better efficacy comparable to that of 

glimepiride and metformin combination and resulted in a better 

adverse effect profile with lower risks of hypoglycemia and 

weight gain [6]. Yavropoulou et al. concluded that vildagliptin 

is well tolerated either as monotherapy or in combination but 

the majority of patients require add-on therapy shortly after the 

beginning of treatment [7]. Our study attempted to compare the 

safety and efficacy of Vildagliptin –Metformin with 

Glimepiride –Metformin in type 2 diabetes mellitus patients.  

MATERIALS AND METHODS  

A 



Kareenmulla et al                                       Efficacy, Safety of Vildagliptin-Metformin versus Glimepiride-Metformin 

Vol 1 | Issue 2 | Jul - Sep 2022                                                                                        Indian J Pharm Drug Studies | 64  

Study design: This study was a prospective observational study 

and was carried out at a tertiary care hospital in Southern India 

over a period of 6 years (from December 2020 to May 2021) 

after due clearance from the institutional ethical committee.  

Inclusion criteria: Male and female patients aged from 2070 

years who gave consent for participation, who are consulting 

both IP and OP general medicine departments suffering from 

type 2 diabetes mellitus with or without comorbid conditions 

with respect to the cardiovascular system and pulmonary system 

and receiving Vildagliptin Metformin and Glimepiride- 

Metformin as a treatment for type 2 diabetes mellitus, are 

included in the study.  

Exclusion criteria: Pregnant women, breastfeeding women, 

neonates, children, and geriatric (>70 years), those who were 

not willing to participate, and those who were suffering from 

type 1 diabetes mellitus, chronic renal or hepatic disorders, and 

receiving insulin treatment are excluded from the study.  

Study method  

Our study was a prospective observational study conducted on 

100 patients with type 2 diabetes mellitus who were on 

treatment with either Vildagliptin - Metformin or Glimiperide – 

Metformin at a government general tertiary care hospital. This 

study was conducted over a period of 12 weeks –follow-up was 

conducted every 4 weeks and the obtained values were 

evaluated. The present study aimed to compare the efficacy and 

safety of the combinations of two different drug regimens i.e., 

Vildagliptin – Metformin and Glimiperide – Metformin in type 

2 diabetic patients.  Patients diagnosed with type 2 diabetes 

mellitus and prescribed metformin-vildagliptin (Group I), and 

metformin-glimepiride (Group II) were screened. Screened 

patients were recruited after taking Informed consent and then, 

data was copied in our data collection form for every follow-up 

that was conducted once in 4 weeks. Group I and Group II 

patients continued the treatment for a duration of 6 months. 

After the end of 6 months, the efficacy and safety profiles of 

both the groups were estimated and compared simultaneously. 

Data were processed and analyzed, and framing of results, 

preparation of dissertation book, and communication of the 

research work through publications were performed.  

Results were represented as frequencies, percentages, mean, 

and medians. Software Graph pad prism was applied to evaluate 

and analyze the data. In some cases, inferential statistics like 

Analysis of variance (ANOVA) followed by student– tests, 

using SPSS software version 21.0 were also implemented. 

Permission for collecting patient data was approved by the 

Institutional Ethical Committee of RIMS hospital and the 

Clinical guide of the General medicine department. In addition, 

hospital management also allowed us to utilize the other 

facilities for the project.  

RESULTS 

A total of 100 patients were taken as the sample size in this 

study. Among them, 65(65%) were male patients and 35(35%) 

were female patients. Based on their treatment, 50 patients were 

grouped in the V-M group and 50 patients were grouped in the 

G-M group. The In V-M group, 35 (70%) patients were male 

and 15(30%) were female patients. In the G-M group, 30(60%) 

were male patients and 20(40%) were female patients. The 

details were shown in Figure 1.  

 

Figure 1: Graphical representation of male & female 

patients (V-M; G-M) 

 A total of 50 patients were in the V-M group, the majority 

of them i.e., 22 (44%) were in the 50-59 years age group, 2(4%) 

patients belonged to the 20-29 years age group, 6(12%) patients 

belonged to 30-39 years age group, 9(18%) patients belonged to 

40-49 years age group, and 11(22%) patients belonged to 60-69 

years age groups. A total of 50 patients were in the G-M group, 

the majority of them i.e., 20(40%) were in the 40-49 years age 

group, 4(8%) patients belonged to the 20-29 years age group, 

2(4%) patients belonged to 30-39 years age group, 16(32%) 

patients belonged to 50-59 years age group and 8(16%) patients 

belonged to 60-69 years age group.  Of a total of 100 patients, 

the majority of them i.e., 38 were in the geriatric age group i.e., 

50-59 years, 6 patients belonged to the 20-29 years age group, 8 

patients belonged to the 30-39 years age group, 29 patients 

belonged to 40-49 years age group, and 19 patients belonged to 

60-69 years age groups. The details have been represented in 

Figure 2.  

 

Figure 2: Graphical representation of patients-based age 

groups (V-M; G-M)  

  

V - M  
35 

V - M  
15  

G - M  
30  

G - M  
20  

0  

5  

10  

15  

20 

25 

30  

35 

40 

Males Females  GENDER 

  

2 
6 

9 

22 

11 

4 
2 

20  

16  

8  

0 

5 

10 

15 

20 

25 

20-29 30-39 40-49 50-59 60-69 

AGE GROUPS 



Kareenmulla et al                                       Efficacy, Safety of Vildagliptin-Metformin versus Glimepiride-Metformin 

Vol 1 | Issue 2 | Jul - Sep 2022                                                                                        Indian J Pharm Drug Studies | 65  

In the total of 50 patients in the V-M group, 33 comorbid 

conditions were present. Among all co-morbidities, majorly i.e., 

13(40%) co-morbidities were found to be hypertension, 4(12%) 

co-morbidities were found to be cardiac arrhythmia, 3(9%) co-

morbidities were found to be coronary artery disease, 9(27%) 

co-morbidities were found to be COPD, and 2(6%) co-

morbidities were found to be pneumonia and asthma. In the total 

of 50 patients in the GM group, 35 co-morbid conditions were 

present. Among all co-morbidities, majorly i.e., 14(40%) co-

morbidities were found to be hypertension, 5(14%) co-

morbidities were found to be coronary artery disease, 10(28%) 

co-morbidities were found to be COPD, and 2(6%) co-

morbidities were found to be cardiac arrhythmia, pneumonia, 

and asthma.   

In the total of 100 patients, 68 co-morbid conditions were 

present. Among all co-morbidities, majorly i.e., 27(40%) co-

morbidities were found to be hypertension, 6(9%) co-

morbidities were found to be cardiac arrhythmia, 8(12%) co-

morbidities were found to be coronary artery disease, 19(27%) 

co-morbidities were found to be COPD, and 4(6%) co-

morbidities were found to be pneumonia and asthma. Details 

with regards to co-morbidities were represented in Figure 3.  

 

Figure 3: Graphical representation of patients based on co-

morbidities (V-M; G-M)  

DISCUSSION  

On evaluation, it was found that a significant reduction of 

HbA1C, FBS, and RBS levels was noted in VM group patients 

when compared to GM group patients. In terms of the safety 

profile, more ADRs were noted in GM group patients than in 

VM group patients. We observed that the Vildagliptin-

Metformin combination is a more effective safety treatment for 

type 2 diabetes mellitus than Glimepiride- Metformin 

combination. Metformin is the first-line drug used to treat 

diabetes mellitus. It suppresses hepatic gluconeogenesis and 

glucose output from the liver and enhances insulin-mediated 

glucose uptake and disposal in skeletal muscle and fat. Thus, 

insulin resistance exhibited by type-2 diabetes is overcome. 

Episodes of hypoglycemia are rare while using Metformin [8]. 

If blood sugar levels are not controlled by metformin, then dual 

therapy will be recommended. Sulfonylureas (Glimepiride) is 

the first add-on drug to Metformin in glucose intolerance. 

Glimepiride will increase insulin secretion. They are widely 

used for type 2 diabetes because they improve glycemic control, 

and lack stomatic side effects other than hypoglycemia, and are 

very inexpensive [9]. 

Insulin production is not provoked even at low-glucose 

concentrations risking the production of severe and 

unpredictable hypoglycemia, which may increase the mortality 

rates. To overcome this effect, some other add-on therapies are 

recommended. DPP-4 inhibitors are one of the therapies among 

them, however, they are considered adjuvant therapy agents.  

Vildagliptin is an active and potent DPP-4 inhibitor that binds 

to enzymes covalently. This complex dissociates very slowly 

resulting in the persistent DPP-4 inhibition even after the 

clearance of the free drug from circulation. It decreases the 

degradation of the incretin hormones glucagon-like- peptide-

1(GLP-1) and glucose-dependent insulinotropic peptide (GIP). 

This activity increases levels of active incretins and enhances 

pancreatic islet cell responsiveness to glucose, thus improving 

insulin secretion and reducing inappropriate glucagon 

production, improving insulin sensitivity, reducing fasting, 

postprandial glucose, and HbA1c. Vildagliptin treatment is 

charcharacterizedweightneutral and lipid-neutral effects, a very 

low risk of edema [10]. The episodes of hypoglycemia are also 

rare in DPP-4 inhibitors treatment. Nasopharyngitis and cough 

are common side effects of DPP-4 inhibitors. Angioedema, 

acute pancreatitis, and skin lesion are rare side effects of DPP-4 

inhibitors. HbA1c levels have been decreased rapidly within the 

initial three months of Vildagliptin [11].  

Biswanath et al., Cheli et al., conducted studies that 

concluded that vildagliptin and metformin combination 

provided better efficacy comparable to that of glimepiride and 

metformin combination and resulted in better adverse effect 

profile with lower risks of hypoglycemia and weight gain [12, 

13]. A study conducted by Li-Nong Ji et al. concluded that the 

use of combination therapy with Vildagliptin and Metformin 

will provide good glycemic control and will be better tolerated 

than up-titration of Metformin monotherapy [14]. A study 

conducted by Hye-soon Kim et al., concluded that Glimepiride- 

Metformin combination therapy was more effective in glycemic 

control than Metformin up-titration and was well tolerated in 

type 2 diabetes mellitus patients inadequately controlled by low-

dose Metformin monotherapy [15]. A study conducted by 

Manuel Gonzalez et al.   showed that Glimepiride- Metformin 

demonstrated to be more efficacious than Glibenclamide- 

Metformin at reaching the glycemic control goals with less 

hypoglycemic events in patients with uncontrolled type 2 

diabetes mellitus [16].  

In the present study, the average HbA1c levels of V-M 

group patients were 7.25% at the start of the study and 6.75% at 

the end of the study. The average HbA1c levels of G-M patients 

were 7.50% at the start of the study and 7.15% at the end of the 

study. The difference between initial i.e., at the start of the study 



Kareenmulla et al                                       Efficacy, Safety of Vildagliptin-Metformin versus Glimepiride-Metformin 

Vol 1 | Issue 2 | Jul - Sep 2022                                                                                        Indian J Pharm Drug Studies | 66  

(week 0) and final i.e., at the end of the study (week 12) of both 

groups were 0.50% and 0.35% respectively. We observed that 

there was a significant reduction of HbA1c levels in V-M group 

patients than in GM group patients, represented in Table 1.  

Table 1: Comparison of average HbA1c levels (V-M; G- M)  

 HbA1C levels monitoring  

Group  At week 0  At week 12  Difference  

V-M  7.25%  6.75%  0.50%  

G-M  7.50%  7.15%  0.35%  

While FBS monitoring, the average value at the initial 

reading (week 0) was 145 mg/dl and 138mg/dl, 133mg/dl, 

125mg/dl on subsequent i.e., 1 st, 2nd, 3rd follow-ups respectively 

in V-M group patients. The average value at the initial reading 

(week 0) was 142mg/dl and 137mg/dl, 135mg/dl, 130mg/dl on 

subsequent follow-ups i.e., 1 st, 2nd, 3 rd follow-ups respectively 

in G-M group patients. The difference between the initial 

reading and final follow-up was 20mg/dl in the V-M group and 

12mg/dl in G-M group patients. It was evaluated that FBS 

reduction was significantly higher in V-M group patients than 

in G-M group patients, tabulated in Table 2.  

Table 2: Comparison of average FBS levels (V-M; G-M)  

FBS (mg/dl) Monitoring 

Group Initial reading 1st Follow up 2nd
 Follow up 3rd Follow up Difference between Initial reading 

and 3rd  Follow up 

V-M 145 138 133 125 20 

G-M 142 137 135 130 12 

 

The average value of RBS levels at the initial reading (week 

0) was 270 mg/dl and 245mg/dl, 210mg/dl, 185mg/dl on 

subsequent i.e., 1st, 2nd, 3rd follow-ups respectively in the V-M 

group patients. The average value of RBS levels at the initial 

reading (week 0) was 250mg/dl and 235mg/dl, 205mg/dl, 

195mg/dl on subsequent follow-ups i.e., 1st, 2nd, 3rd follow-ups 

respectively in G-M group patients. The difference between the 

initial reading and final follow-up was 85mg/dl in the V-M 

group and 55mg/dl in the G-M group patients. It was noticed 

that RBS was notably depleted in V-M group patients than in G-

M group patients. The details were summarized in Table 3. In 

terms of safety profile, ADRs were considered. In the total of 50 

patients in the V-M group, 24 adverse drug reactions were noted 

in 18 patients. The number of ADRs with respect to abdominal 

pain was 8, ADRs of muscle tenderness were 6, ADRs of weight 

gain, and diarrhea were 4, and ADR of hypoglycemia was 2.  

Table 3: Comparison of average RBS levels (V-M; G-M)  

RBS (mg/dl) Monitoring 

Group Initial reading 1st Follow up 2nd Follow up 3rd Follow up Difference between Initial reading 

and 3rd  follow up 

V-M 270 (mg/dl) 245 (mg/dl) 210 (mg/dl) 185 (mg/dl) 85 (mg/dl) 

G-M 250 (mg/dl) 235 (mg/dl) 205 (mg/dl) 195 (mg/dl) 55 (mg/dl) 

 

In the total of 50 patients in the G-M group, 46 adverse drug 

reactions were noted in 32 patients. The number of ADRs with 

respect to abdominal pain was 12, ADRs of muscle tenderness 

were 6, ADRs of weight gain, and diarrhea were 10, and ADRs 

of hypoglycemia was 8, which were represented in Table 4.  

Table 4: Comparison of adverse drug reactions (V-M; G-M)  

Adverserug 

reactions  

V-M           

(N=24)  

G-M  

(N=46)  

Number of 

ADR’s(N=70)  

Hypoglycemia  2  8  10  

Weight gain  4  10  14  

Muscle tenderness  6  6  12  

Abdominal pain  8  12  20  

Diarrhea  4  10  14  

  In a total of 100 diabetic patients who were on the treatment 

of either vildagliptin- metformin or glimepiride- metformin; 70 

adverse drug reactions were experienced by 50 patients. The 

number of ADRs with respect to abdominal pain was 20, ADRs 

of muscle tenderness were 12, ADRs of weight gain, diarrhea 

were 14, and ADRs of hypoglycemia wwas10. In comparison, 

it was found that 24 adverse drug reactions were experienced in 

the V-M group, while 46 adverse drug reactions were 

experienced in the G-M group. Details were outlined in Table 5.   

On evaluation, it was observed that there was a significant 

variation between the average HbA1c levels at the initial reading 

and at the end of the study i.e., at the end of 12 weeks in both 

groups and the greatest reduction was observed in V-M group 

patients than in G-M group patients.  

Table 5: Comparison of overall adverse drug reactions (V-

M; G-M)  

Regimen  Number of ADRs  Percentage of ADRs  

V-M  24  36%  

G-M  46  65%  

There was a significant reduction in FBS and RBS levels on 

subsequent follow-ups in each group and a slightly highest 

reduction was observed in the V-M group than in GM group 

patients. In safety profile, there was a significant difference 

between both groups, and most of the ADRs were observed in 



Kareenmulla et al                                       Efficacy, Safety of Vildagliptin-Metformin versus Glimepiride-Metformin 

Vol 1 | Issue 2 | Jul - Sep 2022                                                                                        Indian J Pharm Drug Studies | 67  

G-M group patients than in V-M group patients. For years, the 

American Diabetes Association (ADA) has recommended that 

all people with diabetes aim for a target hemoglobin HBA1C 

level below 7 percent. 

Even more stringent, the American Association of Clinical 

Endocrinologists (AACE) recommends HbA1C targets below 

6.5 percent. Although there's no cure for type 2 diabetes. Studies 

show that it is possible to reverse diabetes through diet changes 

and weight loss can hold normal blood sugar levels without 

medication.  Comparing the efficacy and safety profiles of the 

Metformin-Vildagliptin regimen with Metformin- Glimepiride 

regimen is the main objective of the research study.  This 

research study may contribute to clinical oriental sails in the 

future. Yet, some more studies are needed to make statistically 

significant conclusions.  

CONCLUSION  

Clearly, it is proved that a combination of Vildagliptin and 

Metformin provided better blood glucose control, compared to 

that of glimepiride-metformin treatment. On evaluating the 

adverse drug reactions, treatment with VildagliptinMetformin 

does not appear to be associated with many adverse events as 

treatment with Glimepiride-Metformin. Also, the risk of 

weightgain is lower in V-M group when compared to G-M 

group. The investigators concluded vildagliptin-metformin 

regimen is not only safer but also more effective than 

glimepiride-metformin regimen. Although there is no 

permanent cure for type 2 diabetic patients it is recommended 

that, people with diabetes should choose a variety of fiber-foods 

such as legumes, fiber-rich cereals (≥ 8 gm fiber/serving), fruits, 

vegetables, and whole grain products as they provide vitamins, 

minerals and other substances important for good health. 

Studies shows that it is possible to reverse diabetes and maintain 

normal blood sugar levels without medication through diet 

changes and weight loss. This research study may contribute 

clinical oriented trails in future. Yet, some more studies are 

needed to make statistically significant conclusions.  

ABBREVATONS  

ADA: American Diabetes Association; ADR: Adverse Drug 

Reaction; ANOVA: Analysis of variance; BMD: Bone Mineral 

Density; BMI: Body Mass Index; CDC: Centres for Disease 

Control and Prevention; CHD: Coronary Heart Disease; CI: 

Class Interval; CVD: Cardio Vascular Diseases; DM: Diabetes 

Mellitus; DME: Diabetic Macular Edema; DPP4: Di Peptidyl 

Peptidase Inhibitor; FDA: Food and Drug Administration; 

FPG: Fasting Plasma Glucose; GCP: Good Clinical Practice; 

GFR: Glomerular Filtration Rate; GGH: Government General 

Hospital; GM: Glimepiride – Metformin; HBA1C: 

Haemoglobin a, c Glucohemoglobin; ICD: Informed Consent 

Document; ICH: International Council of Harmonisation; 

IDDM: Insulin Dependent Diabetes mellitus; IDF: 

International Diabetes Federation; IDH: Intra Dialytic 

Hypotension; IEC: Institutional Ethical Committee; IGT: 

Impaired Glucose Tolerance.  

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Vol 1 | Issue 2 | Jul - Sep 2022                                                                                        Indian J Pharm Drug Studies | 68  

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How to cite this article: Bingi P, Kareemulla S, 

Himabindu B, Khan DS, Ramu D, Mahammed Rafi S. 

A Comparative Study on Efficacy and Safety of 

Vildagliptin-Metformin Versus Glimepiride-Metformin 

in Type 2 Diabetes Mellitus Patients. Indian J Pharm 

Drug Studies. 2022: 1(2) 63-68.  

Funding: None                Conflict of Interest: None Stated  

 


