Tintu, Chacko (2017) A Comparative Study of Teneligliptin Versus Other Standard Gliptins Used in Type Ii Diabetes Mellitus Patients. Masters thesis, KMCH College of Pharmacy, Coimbatore.
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Abstract
AIM AND OBJECTIVES:To determine the therapeutic efficacy and safety of Teneligliptin when compared with other standard gliptin molecules such as sitagliptin and vildagliptin. OBJECTIVES: Whether this drug used as primary, secondary or add on therapy as third molecule. To find out whether it could be used as a monotherapy in special patients with metformin side effect. Find out the usefulness of the teneligliptin and since it is low cost therapy to be recommended more than the other standard gliptins since it may quite useful in developing country like India. DISCUSSION: The study was designed to compare safety, efficacy and cost effectiveness of teneligliptin, sitagliptin and vildagliptin in type II diabetes mellitus patients. The study was started with 155 patients. Each gliptin were compared with metformin and add on therapy of metformin plus glimepiride. In this study the patients were categorized based on their gender. There were 31 males and 19 females in teneligliptin group, 29 males and 21 females in sitagliptin group and vildagliptin group. The results shows the higher predominance in male for type II diabetes mellitus. This was similar to the previous studies conducted by Bennett et al., and Howteerakul et al., which showed higher prevalence of type II DM in men than women. In this study population was categorized in to 5 groups on the basis of age. Among the 5 groups more number of patients were came under the category of 51-60 and less in 71-80 category. Type II DM is commonly seen in middle-aged individuals, especially after 50 years of age. The mean age in this study was 51-60 years, this fact is supported by the study conducted by Miyako Kishimoto et al., . Among the study population, more number of patients (58%, 54% and54% in group A, B and C respectively) were known to have no family history of type II diabetes mellitus. In this study, 40% patients had a positive family history indicating either one or both the parents had type II DM, which was at one stage or the other transferred from one generation to another. Also this was accordance with larger prospective study conducted by Bennett et al., . Study population was categorized into two groups on the basis of duration of the disease in years. More number of patients were came under category 0-5 years and less in 6-10 years. The average duration of DM in this study was found to be 0- 5 years, which was in line with a previous study conducted by Jeon et al., where the mean duration was 5.89 years.The glycemic efficacy was assessed by analyzing the mean change in the value of Fasting Blood Sugar (FBS), Post Prandial Blood Sugar (PPBS), and Glycated hemoglobin (HbA1C) from the start of the therapy to the end of 3 months study period in each group. Teneligliptin has been demonstrated to improve glycemic control when monotherapy and added to glimepiride, metformin, in patients with type II diabetes. It is confirmed that the combination of Teneligliptin, metformin and glimepiride significantly improved glycemic control. However, in this study, the reduction in HbA1C with teneligliptin monotherapy was greater than those in teneligliptin metformin group and teneligliptin with metformin and glimepiride group. In this study shows at the end of 3 months of dual therapy mean HbA1C, FPB, and PPBS were significantly (p value-≤0.0001) reduced by 7.1±0.5% 123.62±9.31mg/d L and 164.16±35.15mg/d L respectively. At the end of 3 months combination therapy the following results were noted (p value ≤ 0.0001) reduction in HbA1C, FPG, PPG by 7.49±0.48% 121.5±22.69mg/d L and 183.44±19.84mg/d L respectively. The result of this study perfectly complies with the former study conducted by, Kim et al., studied in combination of teneligliptin with metformin in known type II diabetic Korean patients whose glycemic status were not under controlled with metformin monotherapy, this shows teneligliptin add on metformin plus glimepiride therapy shows the significant reduction of glycemic parameter. Another study conducted by in Ghosh et al., (TREAT-INDIA), there was statistically significant improvement in mean HbA1c, FPG, and PPG with teneligliptin therapy. Means changes in HbA1c, FPG, and PPG were 1.37%±1.15%, 51.29±35.41 mg/dL, and 80.89±54.27 mg/dL, respectively. Subgroup analysis revealed that HbA1c (%) reduction with teneligliptin when used as monotherapy, add-on to metformin or add-on to metformin plus combination, was 0.98±0.53, 1.07±0.83, 1.46±1.33, respectively.CONCLUSION: Out of 150 patients, the prevalence of type 2 diabetes mellitus was higher in males than females in age group of 51-60 years and most of the patients were observed in the duration was 0-5 years. From this study it was observed that only female patients having the comorbid conditions were thyroid and rheumatoid arthritis. This study provides an evidence of safety and efficacy of teneligliptin as a monotherapy or in combination therapies with a Metformin and Glimepiride in patients with type II Diabetes mellitus. The results pointed out that all the group of patients showed an improvement in their glycemic parameters such as FBS, PPBS, and HbA1c during the study period and from the group comparison study it was observed that the patients receiving combination therapy of teneligliptin have better glycemic control than combination therapy of vildagliptin. The study demonstrated the effectiveness of teneligliptin combination and sitagliptin combination therapy in type II diabetes mellitus patients. Both the combinations on comparison reveled similar efficacy in glycemic parameter, there by failing to prove the superiority in over each other. There was no significance difference was found in SrCr and SGPT level for the follow-up of 3 months therapy with teneligliptin combinations, sitagliptin combinations and vildagliptin combinations. No severe ADR were reported in the 3 groups. All the ADR reported during the study were mild. However the incidence of ADR were numerically more in vildagliptin combination therapy and the incidence of hypoglycemia is more in sitagliptin combination therapy. The teneligliptin combination shows lesser side effects than the other two combinations. Vildagliptin group shows ADR like GI irritation, Hypoglycemia, Headache and Dizziness. In that occurrence of hypoglycemia were high and other ADRs were mild. Sitagliptin groups shows ADRs like GI irritation, head ache, nausea and diarrhea, in that the major ADR was GI irritation. Compare to the other two groups of combination drugs, teneligliptin has less ADRs like GI irritation, Hypoglycemia and Diarrhea. There was no incidence of renal and hepatic toxicity with all the three combination drugs. The cost effective analysis of teneligliptin, sitagliptin, and vildagliptin monotherapy and their combination with metformin was done , the results shows that teneligliptin alone and its combination with metformin was found to be more cost effective than the other groups of drugs. The teneligplin has more advantages than the other two gliptins in type II diabetes mellitus patients. Teneligliptin with metformin and sulfonyl urea treatment was effective and well tolerated in patients with type II diabetes and it has long halflife of 26.9 hours with unique pharmacokinetic advantage which allows convenient once daily administration irrespective of food. It has dual mode of elimination via renal and hepatic, hence it can be administered safely in renal impairment patients. No dosage adjustment is required in mild to moderate hepatic impairment. The appropriate approach towards managing diabetes should be not only glycemic control but also preservation of islet cell function early and to delay the progression of a disease. In conclusion teneligliptin significantly improves glycemic parameters in Indian T2DM patients with mild ADRs when prescribed as monotherapy or as add-on to Metformin and Sulfonyl ureas and it also cost effective than the other gliptins.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Teneligliptin Versus ; Standard Gliptins ; Type Ii Diabetes ; Mellitus Patients |
| Subjects: | PHARMACY > Pharmacy Practice |
| Depositing User: | Ravindran C |
| Date Deposited: | 19 Dec 2017 07:23 |
| Last Modified: | 19 Dec 2017 07:23 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/4465 |
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