Satheesh, K (2022) A Multicentric, Randomized, Open Label study on Comparison of Pancreatic Beta Cell Recovery and Preservation in Type 2 Diabetic Patients treated with DPP-4 Inhibitor and Metformin. Doctoral thesis, The Tamil Nadu Dr. M.G.R. Medical University, Chennai.
Full text not available from this repository.Abstract
INTRODUCTION: Type 2 diabetes (T2D) is a major chronic metabolic disorder. Insulin resistance and pancreatic islet beta cell defect are the characteristic pathophysiologic findings in T2D. Long-term studies conducted globally show that uncontrolled glycemia leads to micro and macrovascular complications. To prevent the occurrence of vascular complications of T2D and its related costs, early treatment is necessary. Hence, it is vital that glycaemic control by appropriate interventions should start early, even with the use of antidiabetic drugs. The risk of complications begins in the prediabetic phase itself. Good control of diabetes reduces the complications significantly. AIM OF THE STUDY: To compare the effect of Vildagliptin versus Metformin on pancreatic beta cell function for two years among newly diagnosed, non-obese Asian Indians with Type 2 diabetes. METHOD: We randomised 203 (104 men 99 women) newly diagnosed type 2 diabetes patients (mean age 47.0 ± 8.1 years, body mass index 23.7 ± 1.4 kg/m2) into two groups. Group 1 treated with Metformin (n = 100), and Group 2 was treated with Vildagliptin (n = 103). The primary outcome measure was to compare the effects of Vildagliptin versus Metformin on pancreatic beta cell function in type 2 diabetes patients at two years. RESULTS: Among the 100 patients randomised to Metformin group, 51 % required only monotherapy and 49 % required the rescue medication. Among the 103 persons, in the Vildagliptin group, 42.7 % required only monotherapy, and 57.3 % required the rescue medication. At the end of the study, there were 12.3 % dropouts and 11.8 % excluded due to lack of glycemic control. The response rate was 87.7 % with a mean duration of follow-up of 80.5 weeks. Totally 36 % of participants in the Metformin group and 27.2 % in Vildagliptin group completed the study with monotherapy. The percentage of patients requiring rescue medication in both groups was similar. However, at 3rd month itself, a higher percentage of patients on Vildagliptin (32%) required the rescue drug when compared with Metformin (18%, χ2 = 3.99, p = 0.046). The median duration of monotherapy was 48 weeks (25 – 70) for both groups. A reduction in Area Under the Curve Insulin (AUCins) was seen in the Metformin group at 6th month (3806.8 ± 1831.8 pmol/l, p = 0.045) and at one year (6389.2 ± 2652.0 pmol/l, p = 0.022) when compared with baseline value. Area Under the Curve Insulin/Glucose (AUCins/glu) and 2h postprandial C-peptide remained the same throughout the study. Insulin sensitivity (Matsuda Index) increased significantly at 6th month (0.7 ± 0.2, p = 0.003) and at 1 year (0.9 ± 0.3, p = 0.006) when compared with baseline value. There was a significant decrease in the glycemic level in Metformin treated patients till 18 months as shown by a reduction in Glycated haemoglobin A1c (HbA1c) and fasting plasma glucose. Vildagliptin resulted in a significant decrease in Area Under the Curve Glucose (AUCglu) at one year (100.8 ± 45.0 mmol/l at one year, p = 0.034 vs baseline). The decrease in AUC glu not associated with increased insulin secretion or increase in 2h postprandial C-peptide levels. The reduction in glycemia persisted for 18 months as shown by the values of HbA1c, fasting plasma glucose and 2h postprandial plasma glucose. In Metformin-treated patients, higher baseline HbA1c was a predictor of the requirement of a second anti-diabetic drug (cut-off value ≥ 7.7 %). The baseline C-peptide did not have an influence. In the case of Vildagliptin, lower baseline HbA1c (cut-off value < 7.4 %) and higher C-peptide (cut-off value > 2.6 pmol/ml) prevented the need for an additional drug. Adverse events: The proportions of patients who developed gastrointestinal disturbances were similar in both the groups. There was no incidence of hypoglycaemia in the Vildagliptin group and two episodes in the Metformin group. CONCLUSION: Both Metformin and Vildagliptin have protective effects on the beta cell function, reduce insulin resistance and glycemic levels. Metformin increased insulin sensitivity also. Higher C-peptide and lower HbA1c values at baseline predicted better glycemic control with Vildagliptin. Lower baseline HbA1c predicted good glycemic control with Metformin.
| Item Type: | Thesis (Doctoral) |
|---|---|
| Additional Information: | 54283/2013 |
| Uncontrolled Keywords: | Multicentric, Randomized, Open Label study, Comparison, Pancreatic Beta Cell Recovery, Preservation, Type 2 Diabetic Patients, DPP-4 Inhibitor, Metformin. |
| Subjects: | Respiratory Medicine > Diabtology > Respiratory Medicine > Diabtology |
| Depositing User: | Subramani R |
| Date Deposited: | 25 Dec 2022 14:47 |
| Last Modified: | 22 Jan 2023 03:03 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21061 |
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