Kissei Pharmaceutical Co., Ltd and Takeda Pharmaceutical Company Limited announced that an additional indication of combination therapy with alpha-glucosidase inhibitor (alpha-GI) for Glufast (mitiglinide) 5mg tablet and 10mg tablet, which is being co-marketed by Kissei and Takeda, was approved on May 24 by the regulatory authority in Japan.
Glufast, originally created and developed by Kissei, co-marketed in tandem with Takeda in Japan since May 2004, is a diabetic medicine that promotes insulin secretion by stimulating the pancreatic ß-cells. It demonstrates effects promptly after dosing, thereby it brings insulin secretion closer to its natural patterns and improves postprandial hyperglycemia. Because of its duration of action, Glufast is less liable to trigger hypoglycemia. Alpha-GI is also a diabetic medicine that decreases the absorption of carbohydrates from the intestine, resulting in a slower and lower rise in plasma glucose after meals by inhibiting degradation of disaccharide into monosaccharide. Takeda is marketing Basen (vogli-bose) tablet in Japan.
In the randomized, double-blind, controlled comparative study, in which clinical usefulness of alpha-GI monotherapy and that of Glufast/alpha-GI combination therapy were evaluated, the latter showed a statistically significant difference in improving HbA1c that is an indicator of glycemic control, without increasing the risk of hypoglycemia.
With this additional indication of combination therapy of Glufast/alpha-GI, it becomes feasible to pursue better glycemic control, providing further treatment options for patients with type 2 diabetes and physicians who treat them. In addition, the findings from this combination therapy showed an improvement of glucose spike, a sharp rise in blood glucose following a meal which is a risk factor for atherosclerosis, and subsequently for cardiovascular risks such as myocardial infarction. Therefore, it is expected that this combination therapy could be a potential for reducing the above risks.