A COMPARATIVE STUDY OF EFFICACY ON GLYCEMIC CONTROL BY GLIMEPIRIDE VERSUS TENELIGLIPTIN AS AN ADD ON TO METFORMIN THERAPY IN TYPE 2 DIABETES MELLITUS PATIENTS

Objective: In our study, the objective was to evaluate the effectiveness of glycemic control of Glimepiride versus Teneligliptin for 2nd-line therapy in combination with Metformin in T2DM patients. 
Methods: A Randomized, Observational, Prospective study has been conducted in outpatient and inpatient departments of General Medicine in RVM Hospital (Laxmakkapally, Mulugu, Siddipet, Telangana). A total of 100 patients with T2DM were recruited in our study in which 50 patients were in Group A (Metformin-Glimepiride) and the other 50 patients were in Group B (Metformin-Teneligliptin). The comparative assessment of efficacy was conducted using glycemic parameters such as FBS, PPBG and HbA1c to interpret the results. 
Results: The mean difference values of HbA1c pre-treatment and post-treatment of Group A were calculated as 1.47 and of Group B was 0.83. The mean difference values FBS pre-treatment and post-treatment of Group A were found to be 56.96 and Group B was 29.62. The PLBS mean difference at Pre-treatment and Post-treatment of Group A and Group B was obtained to be 115.8 and 52.58, respectively. 
Conclusion: From the results obtained, we hereby conclude that, though there was no large difference between the lowering of HbA1c values by two Groups, the FBS and PLBS levels were diminished significantly by Group A (Metformin-Glimepiride) than Group B (Metformin Teneligliptin). Therefore, Glimepiride is considered to be more beneficial than Teneligliptin when combined with Metformin Monotherapy.


INTRODUCTION
Diabetes is a continual metabolic ailment characterized by way of the presence of hyperglycemia because of defective insulin secretion, faulty insulin action, or both. Diabetes is often classi fied into the subsequent general categories: • Monogenic diabetes syndromes • Exocrine pancreas diseases (cystic fibrosis and pancreatitis) • Diabetes induced by drugs (use of glucocorticoids, HIV/AIDS treatment, etc.) Type 2 Diabetes Mellitus is a progressive heterogeneous disorder characterized with various degrees of resistance of insulin and pancreatic β-cell dysfunction due to interaction between several environmental and genetic factors, resulting in increased glucagon production, hyperglycemia and probably reduced PLBS GLP-1 secretion. Concurrent alterations in β-cell function include a duration of compensatory hyperinsulinemia with an irregular secretory structure. The deterioration in β-cell function tends to cause persistent hyperglycemia (glucotoxicity), chronic nonesterified exposure to fatty acids (lipotoxicity), oxidative stress, inflammation and amyloid formation.
The various risk factors include overweight, unhealthy diet, physical inactivity, increasing age, high BP, ethnicity, defective glucose tolerance and history of diabetes in their family [1]. Management includes lifestyle interventions, medications, regular monitoring for complications and laboratory assessment. The goal of treatment is to achieve normal sugar levels in the blood without extremely increased or decreased sugar level and prevention of microvascular and macrovascular complications [2-7]. The ADA recommends Metformin for the initial pharmacological analogue. However, maximum sufferers will require a combination pharmacological remedy to attain healing goals, whilst metformin monotherapy is inadequate to reach or hold goal desires as the second-line remedy.
Sulfonylurea is a common 2nd-line remedy due to its speedy onset of glucose-reducing effect. DPP-4 inhibitors show a glycemic-reducing impact than SU. Besides, DPP-4 inhibitor is more costly than SU. This observation helped the physicians in providing the patient targeted method. SU is the older drug regarded for decades, the whole magnificence of medication cannot be considered homogenous that's presently observed in the case of Glimepiride, SU which has precise characteristics consisting of affiliation of decrease low sugar levels and weight neutral impact. Our goal turned to find the efficiency of antidiabetic tablets-Glimepiride and Teneligliptin for 2nd-line therapy further to stable doses of Metformin [8][9][10][11][12][13][14].

Aim
A comparative study of efficacy on Glycemic control by Glimepiride versus Teneligliptin as an add on to Metformin therapy in T2DM patients.

Objectives
In our study, we evaluated the glycemic control of Glimepiride versus Teneligliptin for 2 nd -line therapy combined with Metformin in T2DM patients and to assess the glycemic triad reports of the subjects.

MATERIALS AND METHODS
The study is a randomized, prospective, observational study at RVM Institute of Medical Sciences and Research Centre, Laxmakkapally, Siddipet. The duration of the study was for 6 mo after approval by

RESULTS
A total of 100 patients were recruited in the study who met the eligibility criteria from both Outpatient and Inpatient Departments.
The mean age of the population in our study was 50.84±9.573 ( fig. 1).

Fig. 1: Age distribution
The pre-treatment value of Group A was 169.78±30. 14 . 3).   15, 0.0000*) respectively and the mean was calculated to be 52.58. Individual Group B Pre-treatment and Post-treatment HbA1c values were 7.30±0.97and6.47±0.55with t-value and P-value (10.60, 0.0000*) and the mean difference was calculated to be 0.83( fig. 6).  Among 100 patients taken in the study, 54% were males and 46% were females, indicating a high prevalence in males according to our study. The mean age of the subjects recruited in the study was 50.84. The maximum percentage of age group enrolled were of 41-50 y group[35%], later comes 51-60 y group[31%]followed by 30-40 y group and more than 60 y group with 19% and 15% respectively. In our present study results are similar with the study conducted by Devarajan et al. [15] and T Nishanth et al. [16].
Group A pre-treatment and Post-treatment HbA1c values were 8.06±1.33 and 6.59±0.56 with t-value and P-value (11.44, 0.0000*) and the mean difference were calculated to be 1.

CONCLUSION
In our present study, we assessed the efficacy of modern Sulphonylurea Glimeperide and Newer DPP-4 Inhibitor Teneligliptin as an add-on to T2DM patients who are presently on Metformin Therapy focusing on the fact that there is a very limited body of studies between Glimiperide and Teneligliptin.
From the results obtained from our study, we hereby conclude that, though there was no large difference in between the reduction in HbA1c values by two Groups, the Blood sugar levels i. e FBS and PLBS were significantly reduced by Group A(Metformin-Glimepiride combination) than Group B(Metformin-Teneligliptin combination) in three months. Therefore, the Metformin-Glimepiride combination is considered to be more efficacious than the Metformin-Teneligliptin combination.

LIMITATIONS
There are certain limitations for our study, which firstly include the small size of the participants' i. e 100 for the ailment like Diabetes mellitus.
Secondly, Short term evaluation of the glycaemic indices for only three months which would oversee the fluctuations in FBS and PPBS, which could be easily affected by the Diet, lifestyle and also the level of medication adherence, Third, Medication costs had influenced the drug of choice in our geographical area due to the socio-economic status of our patients. Hence, a cost-effective analysis of the above-used combinations should be conducted, which would crucially aid in achieving a patient-centered approach.