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On December 22nd 2010, we submitted a written request to the Ministry of Health, Labour and Welfare (MHLW) regarding incretin-based therapies, a new treatment approach for diabetes mellitus.

Type 2 diabetes mellitus accounts for 90 to 95% of the total diabetes patients in Japan. It is thought that type 2 Diabetes Mellitus is caused by a combination of hereditary insulin resistance or abnormal insulin production and environmental factors such as overeating (in particular, excessive fat intake) or lack of exercise.

Several new and emerging drugs for type 2 diabetes, incretin-based therapies with glucose-lowering efficacy by enhancing insulin secretion have recently become available. These include injectable GLP-1 receptor agonists (Byetta: exenatide; Victoza: liraglutide) and oral DPP-4 inhibitors (Equa: vildagliptin, Glactiv: sitagliptin, Januvia: sitagliptin, Nesina: alogliptin). Beneficial effects on glucose control and bodyweight are an attractive feature of the new drugs. However, evidence from clinical trials is limited.

The main aim of diabetes treatment is to prevent the development and deterioration of complications, leading to better quality of life and improvement of life span.

However, the long-term safety of incretin-based therapies has not been established. Furthermore the following two problematic issues of efficacy and safety still remain. Firstly, the use of incretin-based therapies can result in drug-induced hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar). Secondly, beneficial effects on cardiovascular complications have not been established, and no risk assessments have been carried out.

We therefore submitted a written request (summarized as follows) to the MHLW.

<Outline of the request>

Carry out detailed investigation of the safety of incretin-based therapies (DPP-4 inhibitors and GLP-1 receptor agonists), define the mechanism of action and implement countermeasures concerning the following issues:
­¡¡¡DPP-4 inhibitors (Glactiv: sitagliptin, Januvia: sitagliptin): Case reports of hypoglycaemia or severe hypoglycaemia, leading to impaired consciousness.

­¢ GLP-1 receptor agonists (Victoza: liraglutide): Case reports of significantly increased blood glucose or diabetic ketoacidosis (2 deaths reported).

2. ¡ÈGuideline on the evaluation of oral hypoglycaemic agents¡É issued by MHLW should address requirements for clinical trials to investigate the effect of the agents on the occurrence of cardiovascular events.

3. For incretin-based therapies approved before amendment of ¡ÈGuideline on the evaluation of oral hypoglycaemic agents¡É, post-marketing clinical trial (Phase IV study), which is designed with scientific rigor and can investigate the effect of the agents on the occurrence of cardiovascular events should be requested from the MHLW.

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