A study to assess a new antidiabetic drug in Type 2 Diabetic Patients.

• Research type

  Research Study

• Full title

  An open, single-centre, single group, Phase I study to assess the absorption, distribution, metabolism and excretion (ADME) of AZD1656 after oral administration of 14C-labelled AZD1656 to Type II Diabetes Mellitus patients

• IRAS ID

  17221

• Sponsor organisation

  AstraZeneca R&D Mölndal

• Eudract number

  2009-009907-21

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  AZD1656 is a new drug being tested for the treatment of patients with Type II Diabetes Mellitus. This study will be carried out in patients with Type II Diabetes that are treated with metformin alone or together with another oral antidiabetic drug. AZD1656 lowers the blood sugar by increasing the insulin secretion.In order to learn how AZD1656 is absorbed into the bloodstream and how it is then removed from the body, the dose given will have a radioactive marker attached to it. The amount of radioactivity in the blood, urine and faeces will be measured at different times after dosing to assess how rapidly it is eliminated from the body. The total duration of the study will be approximately 6 weeks. This includes 2 screening visits at the clinic. There will be a residential period at the unit of 8 days. Patients will be taking one oral dose of AZD1656 radiolabelled solution. During the study days there will be close monitoring of vital signs (blood pressure, pulse, ECG, laboratory safety sampling) and during the first 24 hours after drug intake there will be continuous ECG recording. In order to learn how AZD1656 is absorbed into the bloodstream and how it is then removed from the body, urine and faeces will be collected and plasma samples will be taken frequently. After the residential period, the patient may need to continue collection of urine and faeces at home for a maximum period of 7 days. There will be a follow-up period after 7-10 days.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/28

• Date of REC Opinion

  4 Jun 2009

• REC opinion

  Further Information Favourable Opinion