Diabetes mellitus (DM) is a metabolic disorder characterized by impaired insulin mediated glucose disposal as a result of absence of insulin, or the inability of the human body to respond to insulin [1]. DM, if left untreated or poorly controlled, is a major cause of morbidity and mortality. This is mostly due to macrovascular and microvascular complications associated with the disease [2-3]. Besides lifestyle changes, an effective strategy to reduce blood glucose levels is represented by anti-diabetic drugs, which largely differ in their mechanism of action. According to the American Diabetes Association (ADA) guidelines, the biguanide metformin (MET), an AMPK (adenosine 50-monophosphate-activated protein kinase) activator [4], is the first-line therapy for T2D. Furthermore, the use of MET in high-risk patients is emerging as a preventive strategy to reduce the incidence of T2DM [5]. Sulfonylurea’s are a class of compounds that stimulate insulin secretion and are currently endorsed as a second-line therapy for the treatment of T2DM patients, either as Monotherapy or in combination with other hypoglycemic agents [6]. Good knowledge about the risk factors of diabetes including age, gender, educational level, the area of residence, BMI, and obesity, family history, and inactive life-style, plays an essential role in prevention and treatment [7]. Despite the large number of OADs, adequate glycemic control (HbA1c < 7.0%) in patients with T2D is difficult to reach. A major cause of therapy failure is poor adherence (often referred to as “compliance”) to OADs, which plays a crucial role in the progression of T2D and risk of diabetes complications [8-9]. Hyperinsulinemic individuals, including type II diabetics and the obese, suffer far greater rates of cancer. Hyperinsulinemic creates chronic inflammation and the generation of free radicals, both of which damage DNA genes needed to regulate healthy cellular proliferation [10].

Aim of this study: To study the demographic profile and levels of serum insulin in patients of type 2 diabetes mellitus taking different oral Antidiabetic agents

This was a cross-sectional observational study carried out in the department of general medicine in a tertiary care centre for a period of one year.

A total of 120 patients of type 2 diabetes mellitus taking Metformin, Sulphonylureas or combination therapy were enrolled in the study.

Inclusion criteria:

• Patients age > 18 years and both gender
• Newly diagnosed Type 2 Diabetes Mellitus as per the ADA criteria
• Type 2 Diabetics Taking Oral Antidiabetic Agents Namely Metformin, Sulphonylureas or Combination with Controlled Sugars for minimum 3 years of duration
• Patients who provided written informed consent for the study
• Exclusion criteria:
• Patients of less than18 years of age
• Pregnant and Lactating females
• Type 2 Diabetes Mellitus patients taking insulin
• Patients who not willing for the study

Patient’s socio-demographic data and detail history about hypertension, diabetes, personal habits, occupation and other systemic affections were recorded.

Detail physical examination including general and systemic examination and anthropometric measurements were carried out and entered in the proforma. Serum fasting Insulin levels were measured. The routine investigation reports available with the patients required for all type Diabetes mellitus patients were entered in case record form

Statistical analysis: Data were entered and analyzed using SPSS version 22. Mean and the standard deviation were calculated for continuous variable. Chi square test was used to compare observed proportions, the difference being significant for p < 0.05.

Out of total 120 patients, 30 were newly diagnosed type 2 diabetes mellitus, 30 patients on Metformin therapy, 30 patients on Glimepiride therapy and 30 were taking both Metformin plus Glimepiride.

Majority of the patients were male (70% in Metformin/Glimepiride group & 63% in both), most of the participants were 41-60 years age group with mean age were 52.2 + 10.5 years. Body mass index (BMI) were significantly higher among patients taking both Metformin and Glimepiride as compared to patients taking Metformin of Glimepiride alone (p<0.05). Waist circumference of male and female were statistically significantly differ between these three groups (p<0.05).

Table1: Socio-demographic profile of the study patients

Serum insulin level was significantly lower (<6 mIU/L) among patients taking Metformin whereas significantly higher (>27 mIU/L) among patients taking Glimepiride therapy.

Table2: Serum insulin levels in patients taking oral hypoglycemic agents

Serum insulin levels were statistically significantly differ among newly diagnosed DM and patients taking oral Antidiabetics drugs (p<0.05).

                Table 3: Comparison of mean serum insulin levels in Type 2 Diabetes Mellitus patients

FBS and PLBS were significantly higher in newly diagnosed diabetics as compared to patients taking oral Antidiabetics. Metabolic lipid profile also significantly de-arranged among newly diagnosed diabetes mellitus patients (p<0.05).

Table 4: Comparison of mean metabolic profile in Type 2 Diabetes Mellitus patients

Poor adherence to oral Antidiabetic therapy represents a major barrier to successful management of T2DM and strongly contributes to the impressive economic burden of diabetes. Indeed, the main consequence of sub-optimal adherence is the enhanced risk of diabetes complications, hospitalization for major disorders, and death, which impact on both health expenditure and efficiency of the healthcare systems [11].

Present study found that majority of patients were among age group of 40 to 60 years with mean age 52.2 + 10.5 years, constant results were reported by Gaikwad M, et al [12] and Samya V, et al [13].

In our study most of the patients were male in all the groups, no significant difference between newly diagnosed T2DM and patients taking oral Antidiabetics, concordance with the other studies: C. Gonzalez et al [14] and Cheng, et al [15].

BMI and waist circumference were significantly differ among newly T2DM and patients taking oral Antidiabetic therapy in the current study (p<0.05), in agreement with the Flier, J.S, et al [16] and Alam MS, et al [17].

We have noted Positive correlation between serum insulin level with Body Mass Index  and Waist circumference in newly detected type 2 DM patients (p value <0.05). Similar results were reported by Nageswara Rao et al [18] and Gill A, et al [19].

Serum insulin levels were significantly higher among patients taking oral Antidiabetics drugs as compared to baseline newly diagnosed T2DM patients (p<0.05), similar findings observed by Sefah, et al [20] and Piragine, E, et al [21].

Present study reported that FBS and PLBS were significantly higher in newly diagnosed diabetics as compared to patients taking oral Antidiabetics, accordance with the Mercedes R. et al [22].

Metformin plus Glimepiride had significant (p <0.05) decrease in serum total cholesterol, LDL and triglycerides and significant increase in HDL as compared from baseline newly diagnosed T2DM, the result was similar to Nissen SE, et al [23].

This study observed the elevated Serum Insulin levels were associated High LDL and Triglycerides level while HDL levels were decreased (p<0.05) in new T2DM patients, results were comparable with the Islam R, et al [24] and Chaudhary G, ET AL [25].

In our study Metformin had significant reduction in Serum total cholesterol and serum LDL and significant increase in serum HDL (P<0.05), whereas Glimepiride had no significant change in serum total cholesterol, LDL, HDL and triglycerides (p >0.05), correlates with the Kakadiya J, et al [26] and Valsaraj S, et al [27].

We have concluded that BMI and waist circumference was significantly differing between newly detected Diabetes Mellitus patients and patients on oral Antidiabetic therapy. The magnitude of association between fasting serum insulin levels and metabolic parameters is statistically significant. Metformin and combination of Metformin and Glimepiride improves the lipid profile, however Glimepiride alone doesn’t affect lipid profile.

Conflicts of interest: None

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