Evaluation of AZD1656 as Add-on Treatment in Type 2 Diabetes Mellitus

• Research type

  Research Study

• Full title

  A 4-month, Randomised, Double-blind, Placebo-and Active-Controlled, Multi-centre, Parallel-Group study to Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus Patients.

• IRAS ID

  29862

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2009-012612-41

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a 4 month, randomised, double-blind, placebo- and active-controlled, multi-centre study of AZD1656 as an add-on to metformin, in approximately 540 Type 2 Diabetes patients. Treatment with glipizide will be included in a separate treatment arm as add-on treatment to metformin, in order to generate data on a comparator in the same study setting. The purpose of this research study is to assess the safety, effectiveness and tolerance of different doses of the study drug AZD1656 and metformin and compare these to placebo (a dummy medication that looks like the real medication but has no active ingredients) and metformin. In addition the study will assess and compare safety, effectiveness and tolerance of glipizide and metfomin in participants with Type 2 Diabetes that is not adequately controlled with metformin. The study drug, AZD1656 is an investigational drug which means it has not been approved for use by regulatory agencies. People with type 2 diabetes have high levels of sugar in the blood, due to a combination of lack of sufficient amounts of insulin and resistance to its action. The high level of glucose in the blood can be controlled by diet and exercise however there are instances where this is not the case and glucose lowering medication has to be used. AZD1656 and glipizide are examples of these medicines. Approximately 540 participants will be taking part and the study will last approximately 5 months. The study will take place across 12 countries in Europe, South America and Mexico in approximately 130 centres.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  09/H1306/91

• Date of REC Opinion

  14 Oct 2009

• REC opinion

  Further Information Favourable Opinion