NN9926-3894 (QBR105507)

• Research type

  Research Study

• Full title

  A randomised, partially double-blind, placebo-controlled first human dose trial investigating the safety, tolerability, and pharmacokinetics of single doses of NNC 0113-0987 in oral tablet formulations in a dose escalation manner in healthy subjects, with an intravenous part to assess absolute bioavailability

• IRAS ID

  81781

• Contact name

  stuart mair

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2011-000297-57

• Research summary

  NNC 0113-0987 is being developed for the treatment of type 2 diabetes. Diabetes is adisease that results from a lower than normal action of the hormone insulin. Insulin is normally produced in response to a meal and results in the sugar absorbed from the meal being taken up from the bloodstream into cells. In diabetes a reduction in this action is either due to the body not producing enough insulin (type 1 diabetes) or lack of effect of insulin on the tissues (type 2 diabetes) resulting in high blood sugar levels. Persistent high blood sugar results in complications that can cause heart attacks, strokes, blindness, impotence and kidney failure. Diabetes is amongst the five leading causes of death by disease in most countries and new treatments are needed. There exist several oral (by mouth) anti-diabetic drugs, however, a large proportion of people with type 2 diabetes do not achieve the recommended target levels of glucose and there is still a need for alternative treatments. Therefore, NNC 0113-0987 is being developed for oral administration and this will be the first time that NNC 0113-0987 together with sodium caprate will be given by the oral route. This will also be the first time that NNC 0113-0987 will be given by injection.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0084

• Date of REC Opinion

  6 Jul 2011

• REC opinion

  Further Information Favourable Opinion