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Combination of Vildagliptin and Pioglitazone in patients with type 2 diabetes
Vildagliptin ( Galvus ), a new once-daily oral treatment option for type 2 diabetes, has demonstrated efficacy, especially in patients with poor glycemic control, as well as weight loss benefits in obese patients.
Vildagliptin, a member of the DPP-4 inhibitor class, works through a novel mechanism of action targeting the pancreatic islet dysfunction that causes high blood glucose levels in people with type 2 diabetes.
Specifically, islet dysfunction can lead to excess glucose production ( via glucagon from the alpha-cells ) and reduced insulin production ( from the beta-cells ).
Vildagliptin affects both pancreatic alpha and beta cells.
The combination of Vildagliptin and Pioglitazone ( Actos ) led to an overall 1.9% reduction in HbA1c.
Pioglitazone is an insulin sensitizer known as a thiazolidinedione, or TZD.
Two-thirds of people ( 65% ) on Vildagliptin and Pioglitazone achieved the ADA-defined A1c goal of less than or equal to 7% versus 42% of those who achieved this goal on monotherapy ( Vildagliptin 42.5%, Pioglitazone 42.9% ).
More importantly, a reduction of up to 2.8% in A1c was seen among patients with poor glycemic control who had the highest mean baseline blood glucose levels ( about 10% ) as measured by A1c.
Patients over age 65 who were given Vildagliptin and Pioglitazone showed an A1c drop of 2.3% from a mean A1c baseline of 8.4%.
In obese patients, with a Body Mass Index ( BMI ) equal to or over 35, patients given Vildagliptin and Pioglitazone showed a decline of 2.2% from a mean A1c baseline of 8.6%.
The study evaluated 592 patients who had never been previously treated for type 2 diabetes and who had a baseline A1c of between 7.5% and 11%. It involved four treatment groups: (1) Vildagliptin 100 mg; (2) Pioglitazone 30 mg; (3) Vildagliptin 100 mg + Pioglitazone 30 mg; (4) Vildagliptin 50 mg + Pioglitazone 15 mg.
Adverse events were consistent with the individual safety profiles of Vildagliptin and Pioglitazone. The patients treated with the combination of Vildagliptin and Pioglitazone experienced no significant additional weight gain and less edema compared to patients taking Pioglitazone alone.
The most common side effects seen in the Vildagliptin clinical program were cold/flu-like symptoms, headaches and dizziness.
Source: 66th Annual Scientific Sessions - American Diabetes Association ( ADA ), 2006
