Announcement for launching GLUBES® in Japan - Fixed dose combination tablet of a rapid-acting insulin secretagogue and improving agent for postprandial hyperglycemia

July 21, 2011, Matsumoto, Japan - Kissei Pharmaceutical Co., Ltd (President, C.E.O. Mutsuo Kanzawa, "Kissei") today announced the launch of GLUBES^®, a fixed dose combination tablet of a rapid-acting insulin secretagogue (generic name: mitiglinide calcium hydrate, hereinafter "mitiglinide") and an improving agent for postprandial hyperglycemia (generic name: voglibose), on July 22, 2011 (National Health Insurance price entry July 19, 2011).

GLUBES^® is a fixed dose combination tablet of mitiglinide (Japanese brand name: Glufast^®) which is a rapid short-acting insulin secretagogue originally developed by Kissei, and of voglibose which is an improving agent for postprandial hyperglycemia. This drug strongly improves postprandial hyperglycemia by inducing the postprandial rapid insulin secretion by mitiglinide and the action of delaying the postprandial digestion and absorption of carbohydrates by voglibose.

The postprandial glucose increase is a typical clinical symptom in the early stage of diabetes. Aggressive treatment of postprandial glucose increase from early stage is thought to be important to inhibit the subsequent progression of diabetes and the development of various complications, including cardiovascular complications.

In the clinical study for the combination therapy of mitiglinide and voglibose, the efficacy of mitiglinide combination therapy was investigated in Type 2 diabetes patients whose blood glucose control was inadequate with the voglibose therapy alone. In patients in the combination therapy group, significant improvements in glucose level for both one hour and 2 hours after meals, HbA1c value and fasting blood glucose were confirmed, compared to those in the group that remained on the voglibose only regimen. Launch of GLUBES^® is expected to improve compliance and reduce financial burden of patients who are already taking both mitiglinide and voglibose. Kissei will make a significant contribution to diabetic care by providing the treatment option utilizing the characteristics of mitiglinide.

Kissei has positioned the metabolic/endocrine area that includes diabetes as one of our core areas of marketing. At present, we are building up our presence in this area by conducting clinical studies in Japan for additional indications for combination treatment of Glufast^® and a Biguanide drug, or a DPP-4 inhibitor.


＜GLUBES^® product　reference＞

Brand Name ：
GLUBES^® Combination Tab.

Ingredients and Quantity ：
It contains 10mg of mitiglinide calcium hydrate and 0.2mg of voglibose in one tablet.

Indications ：
Type 2 Diabetes
In patients appropriate to the treatment in combination therapy of mitiglinide calcium hydrate and voglibose only.

Dosage and Usage ：
Usually, for adults, GLUBES^® Tablet is orally administrated in a single dose of 10mg as mitiglinide calcium hydrate and 0.2mg as voglibose, three times a day, just before each meal.

Characteristics ：
1. GLUBES^® is a new medical fixed dose combination tablet of a rapid-acting insulin secretagogue (mitiglinide, 10mg) and alpha-glucosidase inhibitor (voglibose, 0.2mg).
2. GLUBES^® alone induces the action of a rapid insulin secretion by mitiglinide and the action of delaying the postprandial digestion and absorption of carbohydrates by voglibose.
3. For Type 2 diabetes patients whose blood glucose control was inadequate with the voglibose therapy alone, GLUBES^® has showed significant improvements in postprandial hyperglycemia and HbA1c value, compared to the group that remained on the voglibose only regimen.
4. GLUBES^® has maintained good blood glucose control over a long period of 52 weeks.
5. Dosage and usage of GLUBES^® is orally administrated in a single dose, three times a day, just before each meal. Therefore, the number of medication tablets will be reduced from combination therapy of each single agent.

NHI price ：
GLUBES^® one tablet ¥59.80

Manufactured and Distributed by : KISSEI PHARMACEUTICAL CO., LTD.