galvus ls global clinical studies summary

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Physiology and Pathophysiology of Diabetes

GALVUS Learning System

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Trials of Vildagliptin as Monotherapy

In Study 2384 and Study 2301, compared with placebo, vildagliptin improved glycaemic control and produced clinically meaningful decreases in HbA1c in drug-naïve patients with T2DM.

Study results showed that, overall, vildagliptin was well tolerated at all dose levels (Study 2301), associated with a low incidence of hypoglycaemic events, had a good gastrointestinal tolerability profile compared with metformin (Study 2309), and was weight neutral.

In Study 2309, vildagliptin did not achieve statistical noninferiority to metformin.

In Study 2307E, two-year treatment with the DPP-4 inhibitor vildagliptin in mildly hyperglycaemic patients was well tolerated and appeared to attenuate the progressive deterioration in glycaemic control seen in patients receiving placebo.

In Study 2310, vildagliptin as monotherapy in drug-naïve patients with T2DM appeared to achieve similar efficacy as gliclazide in patients with HbA1c levels of <8% and over a two-year period had significant benefits in terms of weight neutrality and less hypoglycaemia.

Study 23137 showed that vildagliptin added to current therapy elicited robust improvements in glycaemic control, with A1c reductions of -0.7% (from baseline of 7.9% in moderate renal impairment) and -0.9% (from baseline of 7.7% in severe renal impairment).

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Trials of Vildagliptin as Combination Therapy

In Study 2303, 50 mg twice daily vildagliptin added to metformin demonstrated a greater reduction in HbA1c than 50 mg once daily vildagliptin in inadequately controlled patients with T2DM receiving metformin, due to a greater reduction in FPG.

In Study 2354, vildagliptin as an add-on therapy to metformin was shown to be noninferior to pioglitazone in improving glycaemic control in patients with T2DM at 24 and 52 weeks.

In Study 2308, vildagliptin as an add-on therapy to metformin demonstrated less hypoglycaemia and weight neutrality compared to glimepiride, at the same level of glycaemic control in patients with T2DM at 52 and 104 weeks.

In Study 2305, 50 mg once daily vildagliptin add-on therapy to glimepiride monotherapy led to statistically and clinically significant decreases in HbA1c compared with glimepiride plus placebo, and there was no further decrease in HbA1c with 50 mg twice daily. Adding vildagliptin to glimepiride did not cause weight gain and was associated with a very low incidence of hypoglycaemia.

In Study 23135, 50 mg twice daily vildagliptin as an add-on therapy in patients with T2DM who are inadequately controlled by insulin showed that vildagliptin was safe, well tolerated, and weight neutral, with no increases in hypoglycaemia. Also, vildagliptin significantly lowered the HbA1c from baseline to study endpoint.

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Trial of Vildagliptin as Triple Therapy

Study 23152 showed that triple combination therapy with vildagliptin was safe and well tolerated, with a low risk of hypoglycaemia and weight neutrality, making this an attractive treatment addition for patients failing on dual metformin and sulphonylurea therapy.

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Trials of Vildagliptin in Special Populations

In the study of elderly patients, vildagliptin as monotherapy was effective, well tolerated, and noninferior to metformin in improving glycaemic control in elderly patients (≥65 years) with T2DM at 24 weeks.

Data from a pooled analysis demonstrate that vildagliptin is effective and well tolerated in patients ≥75 years with T2DM, either as monotherapy or add-on therapy to metformin.

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Analysis of Pooled Safety Data

Vildagliptin 50 mg once daily and 50 mg twice daily was not associated with a significantly increased risk of CCV events, hepatic events, immune system suppression, skin-related events, or pancreatitis-related events relative to all comparators.

These data indicate that vildagliptin is a well-tolerated agent, with an AE profile that is similar to that of comparators.

galvus ls global clinical studies summary

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