Comparative evaluation of efficacy and safety of combination of metformin-vidagliptin versus metfromin-glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy-A randomised open label study
Aim and Objective: The aim was to evaluate and compare the efficacy and safety of combinations of metformin-vidagliptin (MF-VG) and metfromin-glimepiride (MF-GP) in type 2 diabetes mellitus (T2DM) patients. Materials and Methods: A comparative randomized open-label trial was conducted on patients wi...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2015-01-01
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| Series: | Perspectives in Clinical Research |
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| Online Access: | http://www.picronline.org/article.asp?issn=2229-3485;year=2015;volume=6;issue=3;spage=163;epage=168;aulast=Gupta |
| _version_ | 1819052308295581696 |
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| author | Shallini Gupta Vijay Khajuria Vishal R Tandon Annil Mahajan Zahid H Gillani |
| author_facet | Shallini Gupta Vijay Khajuria Vishal R Tandon Annil Mahajan Zahid H Gillani |
| author_sort | Shallini Gupta |
| collection | DOAJ |
| description | Aim and Objective: The aim was to evaluate and compare the efficacy and safety of combinations of metformin-vidagliptin (MF-VG) and metfromin-glimepiride (MF-GP) in type 2 diabetes mellitus (T2DM) patients. Materials and Methods: A comparative randomized open-label trial was conducted on patients with uncomplicated T2DM, on treatment with MF for 4 months out of which on maximum tolerated dose of MF (1000-2500 mg/day) for 4 weeks, glycosylated Haemoglobin [HbA1c]) ≥6.5%, fasting blood glucose (FBG) ≥126 mg/dl and post prandial glucose (PPG) ≥200 mg/dl were included in the study. Patients were randomized to receive MF (500 mg BD) + VG (50 mg BD) or MF (500 mg BD) + GP (2 mg BD). Results: Both the groups caused significant decline in blood glucose levels both FBG as well as PPG levels (P < 0.01). HbA1c was also reduced significantly in both groups at 12 weeks (P < 0.01). Total serum cholesterol, triglycerides, low-density lipoprotein and very low-density lipoprotein decreased significantly, whereas high-density lipoprotein levels increased significantly from baseline levels in both the groups (P < 0.01). Intergroup comparison failed to demonstrate any statistical difference on all of above parameters. Both weight and body mass index did not alter statistically from baseline in either of the groups as well as demonstrated no difference statistically on comparison (P > 0.05). At the end of the study, both liver functions tests and renal functions tests remained unaltered statistically and within normal clinical range in both the groups (P > 0.05). However, hypoglycemia and other adverse events were numerically more in MF + GP group. Conclusion: Both the regimens on comparison revealed similar efficacy and safety thereby failing to prove superiority over each other. |
| first_indexed | 2024-12-21T12:17:46Z |
| format | Article |
| id | doaj.art-e9e44e8d15684b3583bf909655557ceb |
| institution | Directory Open Access Journal |
| issn | 2229-3485 |
| language | English |
| last_indexed | 2024-12-21T12:17:46Z |
| publishDate | 2015-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Perspectives in Clinical Research |
| spelling | doaj.art-e9e44e8d15684b3583bf909655557ceb2022-12-21T19:04:23ZengWolters Kluwer Medknow PublicationsPerspectives in Clinical Research2229-34852015-01-016316316810.4103/2229-3485.159942Comparative evaluation of efficacy and safety of combination of metformin-vidagliptin versus metfromin-glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy-A randomised open label studyShallini GuptaVijay KhajuriaVishal R TandonAnnil MahajanZahid H GillaniAim and Objective: The aim was to evaluate and compare the efficacy and safety of combinations of metformin-vidagliptin (MF-VG) and metfromin-glimepiride (MF-GP) in type 2 diabetes mellitus (T2DM) patients. Materials and Methods: A comparative randomized open-label trial was conducted on patients with uncomplicated T2DM, on treatment with MF for 4 months out of which on maximum tolerated dose of MF (1000-2500 mg/day) for 4 weeks, glycosylated Haemoglobin [HbA1c]) ≥6.5%, fasting blood glucose (FBG) ≥126 mg/dl and post prandial glucose (PPG) ≥200 mg/dl were included in the study. Patients were randomized to receive MF (500 mg BD) + VG (50 mg BD) or MF (500 mg BD) + GP (2 mg BD). Results: Both the groups caused significant decline in blood glucose levels both FBG as well as PPG levels (P < 0.01). HbA1c was also reduced significantly in both groups at 12 weeks (P < 0.01). Total serum cholesterol, triglycerides, low-density lipoprotein and very low-density lipoprotein decreased significantly, whereas high-density lipoprotein levels increased significantly from baseline levels in both the groups (P < 0.01). Intergroup comparison failed to demonstrate any statistical difference on all of above parameters. Both weight and body mass index did not alter statistically from baseline in either of the groups as well as demonstrated no difference statistically on comparison (P > 0.05). At the end of the study, both liver functions tests and renal functions tests remained unaltered statistically and within normal clinical range in both the groups (P > 0.05). However, hypoglycemia and other adverse events were numerically more in MF + GP group. Conclusion: Both the regimens on comparison revealed similar efficacy and safety thereby failing to prove superiority over each other.http://www.picronline.org/article.asp?issn=2229-3485;year=2015;volume=6;issue=3;spage=163;epage=168;aulast=GuptaGlimepiridemetformintype-2 diabetes mellitusvidagliptin |
| spellingShingle | Shallini Gupta Vijay Khajuria Vishal R Tandon Annil Mahajan Zahid H Gillani Comparative evaluation of efficacy and safety of combination of metformin-vidagliptin versus metfromin-glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy-A randomised open label study Perspectives in Clinical Research Glimepiride metformin type-2 diabetes mellitus vidagliptin |
| title | Comparative evaluation of efficacy and safety of combination of metformin-vidagliptin versus metfromin-glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy-A randomised open label study |
| title_full | Comparative evaluation of efficacy and safety of combination of metformin-vidagliptin versus metfromin-glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy-A randomised open label study |
| title_fullStr | Comparative evaluation of efficacy and safety of combination of metformin-vidagliptin versus metfromin-glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy-A randomised open label study |
| title_full_unstemmed | Comparative evaluation of efficacy and safety of combination of metformin-vidagliptin versus metfromin-glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy-A randomised open label study |
| title_short | Comparative evaluation of efficacy and safety of combination of metformin-vidagliptin versus metfromin-glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy-A randomised open label study |
| title_sort | comparative evaluation of efficacy and safety of combination of metformin vidagliptin versus metfromin glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy a randomised open label study |
| topic | Glimepiride metformin type-2 diabetes mellitus vidagliptin |
| url | http://www.picronline.org/article.asp?issn=2229-3485;year=2015;volume=6;issue=3;spage=163;epage=168;aulast=Gupta |
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