Evaluation of Efficacy and Tolerability of Fixed Dose Combination of Metformin with Voglibose Versus Metformin with Pioglitazone in Prediabetics: An Open label, prospective, RCT

Background: ADA has cut-off value for IGT (140-200 mg/dL) but has a lower cut-off value for IFG (100-125 mg/dL) and has additional hemoglobin A1c (HbA1c) based criteria of a level of 5.7% to 6.4% for the definition of prediabetes. Due to progressive nature of prediabetes, dual drug therapy produces additive effects, allows the use of submaximal doses, and less side effects of individual agents. Therefore, the present study was designed to study the effect of voglibose in comparison to pioglitazone on glycemic control as an add-on drug in prediabetes patients whose glycemic status was uncontrolled with metformin alone. Methods: The present study was open, randomized, parallel group comparison of two active treatment groups over a period of six months. Sixty-seven patients of either sex in the age group of 30-60 years, suffering from prediabetes, with FBG: 100-125 mg/dl and PPBG:140-200 mg/dl as per ADA were selected at randomly. The effect of FDC of Voglibose with Metformin and Pioglitazone with Metformin were observed on various parameters of Glycemic Triad (FBG, PPBG, HOMA-IR, HbA1c and Serum Insulin). Results: At the end of 6 months it was observed that though both FDC of Voglibose with Metformin and Pioglitazone with Metformin reduced Glycaemia Statistically significantly but Pioglitazone with Metformin caused a significantly greater percentage change in Glycaemia as compared with Voglibose with Metformin. Few side effects were observed with Voglibose but not with Pioglitazone. Conclusions: Though Voglibose with Metformin and Pioglitazone with Metformin were equally effective in lowering Glycemia yet Pioglitazone with Metformin showed better results in improving glycaemia, as compared to Voglibose with Metformin. Pioglitazone with Metformin had minimal side effects as compared to Voglibose with Metformin. Keywords: Voglibose, Metformin, Pioglitazone, Prediabetes, Glycemi

Comparative study to evaluate efficacy and safety of azilsartan and telmisartan in patients with grade I-II essential hypertension

Background: Objectives of the study was to study the effect of Azilsartan 40mg once daily versus Telmisartan 40mg once daily in patients with Grade I-II essential hypertension.Methods: A prospective study was conducted at MGM Medical college and Hospital which included 80 patients in each group with Grade I–II essential hypertension. The sex, age, presenting illness, and family history of the patients were recorded. Investigations such as blood sugar, urine analysis, kidney function test, lipid profile, and ECG were performed before starting the treatment. Any adverse effects during the treatment were noted. Blood pressure was recorded at baseline and during follow-up. One group received Azilsartan 40mg once daily and another group Telmisartan 40mg once daily. Patients were followed-up every week for 5 weeks.Results: Patients receiving Azilsartan 40mg and Telmisartan 40mg showed a significant fall (P 0.05). Adverse effects such as Nasopharyngitis, Upper respiratory tract inflammation, Gastroenteritis, headache, dizziness, and fatigue were reported with both drugs.Conclusions: Reduction of blood pressure with Azilsartan and Telmisartan was similar, but fall in blood pressure from baseline was highly significant in both groups

To evaluate the efficacy and safety profile of rosuvastatin, simvastatin and atorvastatin in newly diagnosed type 2 diabetic patients with dyslipidaemia

Dyslipidemia is one of the major risk factors for cardiovascular disease in diabetes mellitus. The lipid changes associated with diabetes mellitus are attributed to increased free fatty acid flux secondary to insulin resistance. Newly diagnosed 90 cases of patients of Type II Diabetes Mellitus well controlled on oral hypoglycemic drugs were randomly divided into 3 groups of 30 each. The mean difference of Triglycerides between baseline versus after 6 months was 65.04 mg/dl in Group A, 39.99 mg/dl in Group B and 37.04 mg/dl in Group C. The mean difference of HDL between baseline versus after 6 months was 10.04 mg/dl in Group A, 10.26 mg/dl in Group B and 9.13 mg/dl in Group C. The mean difference of LDL between baseline versus after 6 months was 79.4 mg/dl in Group A, 67.6 mg/dl in Group B and 33.82 mg/dl in Group C. The mean difference of VLDL between baseline versus after 6 months was 13.01 mg/dl in Group A, 7.58 mg/dl in Group B and 7.41 mg/dl in Group C.&nbsp

To evaluate the efficacy and safety profile of Rosuvastatin, Simvastatin and Atorvastatin in newly diagnosed type 2 diabetic patients with dyslipidaemia

Dyslipidemia is one of the major risk factors for cardiovascular disease in diabetes mellitus. The lipid changes associated with diabetes mellitus are attributed to increased free fatty acid flux secondary to insulin resistance. This is prospective, comparative, open label, randomized and parallel group. The subjects enrolled for this study were selected from the Out-Patient Department of Medicine collaboration with Department of Pharmacology, Tertiary care teaching hospital over a period of month. Newly diagnosed 90 cases of patients of Type II Diabetes Mellitus well controlled on oral hypoglycemic drugs were randomly divided into 3 groups of 30 each. Group A was received Rosuvastain 10 mg O.D for 3 months, Group B: Simvastatin 10 mg O.D and Group C was received Atrovastatin 10 mg O.D. In Group ‘A’ the mean difference of Total Cholesterol between baseline versus after 6 months was 82.37 mg/dl, 64.92 mg/dl and 52.23 mg/dl in Group B and Group C respectively. The mean difference of Triglycerides between baseline versus after 6 months was 65.04 mg/dl in Group A, 39.99 mg/dl in Group B and 37.04 mg/dl in Group C.&nbsp

Association of visceral fat with cardiopulmonary fitness, oxidative stress and inflammatory markers in asymptomatic individuals with and without family history of type 2 diabetes mellitus

Diabetes mellitus (DM) is a metabolic disorder characterized by chronic hyperglycemia with derangement of carbohydrate, fat, and protein metabolism due to absolute or relative deficiency of insulin secretion and action, or both. DM, especially type-2 DM, is a serious general medical issue which has arrived at scourge extents because of the quickly expanding paces of this ailment around the world. Target organ confusions, auxiliary to diabetes, are one of the most significant restorative worries of right now. The main findings of our research were no significant differences in baseline characteristics like age and height of both groups. Weight, BMI and waist hip ratio was significantly high in cases. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and rate pressure product were significantly high in Cases individuals; however, no significant difference was noticed in pulse pressure (PP). Significantly higher body fat and visceral fat %, lower levels of cardio respiratory fitness assess by cooper 12min run test and significantly higher levels of fasting blood sugar (FBS) was observed in cases

Comparative study to evaluate the efficacy and safety of Pioglitazone and Metformin on HOMA IR and HbA1c in patient of prediabetes

In India, the number of people with diabetes is increasing day-by-day. Due to a sole “Asian Indian Phenotype,” Indians develop diabetes an era earlier and have an earlier onset of complications. Hence, it is essential to evaluate earlier stage of disease progression. Prediabetes, typically defined as blood glucose levels above normal but below the thresholds of diagnosis of diabetes, is a risk state that defines a high chance of developing diabetes. The present study was Prospective, open label, comparative, randomized, parallel group, single center study. Comparison of two active treatment groups over a period of six months. Sixty patients of either sex in the age of more than 40 years with prediabetes, with HbAlc in the range of 5.7 to 6.4 % at screening as per ADA. The effect of metformin and pioglitazone were observed on various parameters i.e. Serum Insulin, FBG, HbA1c, HOMA-IR. In metformin group the mean change in HOMA-IR from baseline to 6 months was 3.44 to 2.21 (-1.23); on the other hand, in Pioglitazone group from baseline to 6 months was 3.30 to 1.91 (-1.39). Whereas, serum insulin from 35.58 to 26.73 (-8.85) in metformin group; in Pioglitazone group from 35.13 to 21.77 (-13.36).&nbsp

To evaluate the safety and efficacy of saroglitazar among pre-diabetes and dyslipidemia

Patients with prediabetes are not only at increased risk of progression to type 2 diabetes, but they are also at high risk of developing cardiovascular (CV) risk compared to normoglycemic people. Further, prediabetes is also often associated with abnormal lipid levels (dyslipidemia). We therefore aimed to evaluate the effect of saroglitazar in patients with prediabetes and dyslipidemia. This was a prospective, single centre, single arm study involving patients with pre-diabetes and dyslipidemia. Subjects with baseline HbA1c 5.7-6.4% and dyslipidemia were enrolled in this study. Subjects with on-going medications affecting blood glucose or lipids were excluded from the study. Saroglitazar 4mg once daily was administered for a period of 24 weeks. The primary outcome was change in serum triglycerides and secondary outcome parameters included changes in other lipid parameters and HbA1c levels at 24 weeks follow-up. Forty patients with prediabetes and dyslipidemia were enrolled in the study. At 24 weeks follow-up, serum triglycerides was significantly reduced from 348 mg/dl to 216 mg/dl (P <0.0001). HbA1c was significantly reduced from 6.3% to 5.5% after 24 weeks of Saroglitazar therapy (P<0.0001).&nbsp

Study the effect of Canagliflozin in patients of type 2 diabetes mellitus inadequately controlled on maximum dose of three oral hypoglycemic agents

Metformin is the first- line pharmacotherapeutic agent implemented after life style modification to achieve the desired glycemic levels in patient with T2DM. [4] However, Metformin alone in many patients fail to maintain the desired glycemic levels in long term and they will require additional combination therapies.[5] Even though effective initially , agents included in the class of sulfonylurea has common side effects like hypoglycemia and weight gain.[6] It is also observed that drugs acting on pancreatic β cells will cause early exhaustion of β cells and the use of agents that utilize the insulin dependent pathways. After the analysis of data collected at the end of the study it was found that there was a significant reduction in fasting and post prandial blood sugar levels, HbA1c value and body weight. Along with these benefits few adverse effect including simple urinary tract infection, genital mycotic infection were recorded, these ADRs were mild and symptoms subsided after routine treatment.&nbsp

Comparative study to evaluate safety and efficacy of Metformin versus sitagliptin alone and combination in type 2 diabetes mellitus

Type 2 Diabetes mellitus (Type 2DM) is chronic, lifelong progressive metabolic disease characterized by hyperglycaemia due to absolute or relative insulinopaenia. The metabolic dysregulation that contributes to hyperglycaemia includes diminished insulin secretion, impaired glucose utilization or increased glucose production, and eventually causes pathophysiological changes in multiple organs and organ systems. Our study showed Sitagliptin was superior in reducing HOMA-IR when compared with metformin. If combination of Sitagliptin and metformin is used far superior reduction will be achieved on HOMA- IR. Limitation of our study was short duration of study and small sample size

Study of association of C-reactive protein and alkaline phosphatase in type 2 diabetes mellitus patients

The prevalence and incidence of type 2 diabetes are rising rapidly worldwide, especially in Asia. Diabetes has been linked to a shorter life expectancy mainly because of its complications, including heart disease, strokes, eye disease, inflammation and bone disease. The aim of the study was to examine the relationship between high sensitive C reactive protein (hsCRP) and alkaline phosphatase (ALP) in type 2 diabetes patients. Furthermore, we investigated correlation between serum hsCRP and ALP level with glycaemic triad (FBS, PPBS, HbA1c) in case and control group. A cross sectional study consists of 200 patients out of which 100 normal healthy control (Group I), case - 100 patients having type 2 DM (Group II). FBS, PPBS, HbA1c, hsCRP and ALP were measured.  Mean serum hsCRP and ALP level were statistically significantly higher in case group compared to control group. Moreover, significant positive correlation was observed between hsCRP and ALP level as well as both with FBS, PPBS and HbA1c. Oxidative stress and inflammation appears to be a key component and also associated with poor glycaemic control and further pathogenesis of diabetes and its complications.&nbsp