Once Daily Vildagliptin 100 mg sustained-release therapeutically safe, effective as Vildagliptin 50 mg twice daily add on to Metformin in Indian Diabetics
Vildagliptin 100 mg sustained-release once daily is therapeutically safe and effective as Vildagliptin 50 mg tablet twice daily as an add-on to Metformin in Indian patients with Type 2 diabetes mellitus.
The National Journal of Physiology, Pharmacy and Pharmacology has now published the key results from a Phase IV clinical study comparing the efficacy and safety of Vildagliptin 100 mg sustained-release once daily with Vildagliptin 50 mg tablet twice daily as an add-on to Metformin in Indian patients with Type 2 diabetes mellitus.
This study showed that 100 mg SR vildagliptin once-daily dose along with 1000 mg metformin in two divided doses is equally effective as 50 mg twice daily vildagliptin along with 1000 mg metformin in two divided doses in terms of reducing HbA1C, Fasting Blood Glucose, and Post Prandial Blood Glucose. Both the drugs are equally safe in the parameter of changes in liver enzymes (SGOT and SGPT) and serum bilirubin.
The study recruited a total of 126 adult patients of either gender, aged between 18 and 60 years, and newly diagnosed cases of Type 2 DM with HbA1C ≥6.5 and ≤8. The patients were randomly distributed into two different groups. Patients in Group A received metformin SR 500 mg twice daily after food plus vildagliptin 50 mg twice daily after food. Patients in Group B received metformin SR 500 mg twice daily after food plus vildagliptin 100 mg SR once daily after lunch.
It was seen that treatment with vildagliptin 50 mg twice daily or 100 mg SR formulation once daily, showed a significant decrease in HbA1C%, FBG, and PPBG levels from their respective baseline values for both groups (P < 0.05) [Tables 2 and 3].
The intergroup comparison showed no significant changes in glycemic indices in the 12th week [Table 4].
The findings of the study at least affirm the weight neutrality of vildagliptin whether given as 50 mg twice daily or 100 mg SR dose. Liver enzymes did not show any statistically significant changes at the end of the 12th week in either of the intervention groups. This reassures the safety of SR100 mg vildagliptin given once daily so far as an alteration in liver enzyme parameter is concerned [Tables 5 and 6].
The overall safety and tolerability profiles were similar between the treatment approaches, with no unexpected adverse events.
"There was no difference in hypoglycemic episodes among the two groups. In fact, none of the groups had hypoglycemia. The standard of care, the world standard in vildagliptin therapy is the unmodified vildagliptin 50 milligrams twice daily which is the full dose in patients with normal renal function. And when compared with this world standard regimen of vildagliptin, when we used the sustained release preparation sustainable release formulation of vildagliptin, it came out to be non-inferior to the world standard," said Dr. Nilanjan Sen Gupta, Department of Endocrinology Nil Ratan Silchar Medical College and Hospital, Kolkata and study's co-author in a conversation with Medical Dialogues team.
" There was not any significant change in liver enzymes between the two groups that is 50 milligrams given twice daily and 100 mg once daily. And the question of hypoglycemia also was addressed," Dr Gupta added
Results of the Study:
Table 1: Baseline parameters | |||
Parameter | Group 1 | Group 2 | P‑value |
HbA1C (in %) | 9.13±1.74 | 9.49±1.19 | 0.664 |
FBG (in mg/dl) | 193.6±32.7 | 203.68±38.18 | 0.123 |
PPBG (in mg/dl) | 314.10±68.48 | 314.85±62.06 | 0.95 |
Body Weight (in kg) | 65±5.9 | 63.83±8.23 | 0.37 |
Table 2: Effect of vildagliptin 50 mg twice daily | |||
Parameter | Group 1 | Group 2 | P‑value |
HbA1C (in %) | 9.17±0.954 | 6.641±0.476 | 0.001 |
FBG (in mg/dl) | 194.76±32.65 | 116.0±21.64 | 0.001 |
PPBG (in mg/dl) | 317.09±67.69 | 162.09±12.40 | 0.001 |
Body Weight (in kg) | 64.9±5.96 | 63.64±5.87 | 64.9±5.96 |
Table 3: Effect of vildagliptin 100 mg sustained release tablets once daily | |||
Parameter | Group 1 | Group 2 | P‑value |
HbA1C (in %) | 9.023±1.069 | 6.5±0.45 | 0.001 |
FBG (in mg/dl) | 203.68±38.18 | 115.84±12.91 | 0.001 |
PPBG (in mg/dl) | 311.95±62.34 | 157.51±14.22 | 0.001 |
Body Weight (in kg) | 64.04±8.34 | 63.16±8.24 | 0.04 |
Table 4: Intergroup Comparison | |||
Parameter | Group 1(V50) | Group 2 (V 100) | P‑value |
HbA1C (in %) | 6.64±0.47 | 6.5±0.45 | 0.115 |
FBG (in mg/dl) | 116.0±21.64 | 117.12±10.68 | 0.72 |
PPBG (in mg/dl) | 162.09±12.40 | 157.85±14.10 | 0.08 |
Body Weight (in kg) | 63.64±5.87 | 63.27±8.1 | 0.11 |
Table 5: Effect of vildagliptin 50 mg BID on bilirubin, SGPT, and SGOT | |||
Parameter | Baseline | Week 12 | P‑value |
Bilirubin (in mg/dL) | 0.64±0.23 | 0.62±0.3 | 0.196 |
SGOT (in U/L) | 56±10.75 | 55.92±10.79 | 0.095 |
SGPT (in U/L) | 51.5±6.13 | 52±6.18 | 0.832 |
Table 6: Effect of vildagliptin 100mg SR OD on bilirubin, SGPT, and SGOT | |||
Parameter | Baseline | Week 12 | P‑value |
Bilirubin (in mg/dL) | 0.74 ± 0.170 | 0.75 ± 0.75 | 0.195 |
SGOT (in U/L) | 53.98 ± 7.1 | 53.84 ± 7.3 | 0.911 |
SGPT (in U/L) | 53.53 ± 7.5 | 53.45 ± 7.7 | 0.388 |
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