Evaluation of metformin XR vs metformin IR in monotherapy in T2DM

• Research type

  Research Study

• Full title

  A 24-Week International, Multi-centre, Randomised, Parallel-group, Double-blind Trial to Evaluate Metformin Extended Release Monotherapy Compared to Metformin Immediate Release Monotherapy in Adult Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Diet and Exercise

• IRAS ID

  124224

• Contact name

  Ponnusamy Saravanan

• Contact email

  p.saravanan@warwick.ac.uk

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2012-004531-23

• Clinicaltrials.gov Identifier

  NCT01864174

• Research summary

  A study to determine if therapy with Metformin Extended Release is as effective and safe as therapy with Metformin Immediate Release.
  This study is open to adult patients over the age of 18 who have Type 2 Diabetes Mellitus (T2DM) and have inadequate glycaemic control (the amount of sugar in the blood) using just diet and exercise.
  Metformin is the most common oral medicine given in addition to diet and exercise for blood sugar control in patients with T2DM in the US and the UK. Metformin is available by prescription as an extended release form, which is taken once a day, and as an immediate release form taken 2 to 3 times a day. The 2 treatment regimens are:
  • Metformin Extended Release 2000 mg taken once daily
  • Metformin Immediate release 2000 mg taken as 1000mg twice daily
  Patients will be randomly allocated to one of the two treatment groups. Patients are planned to attend the study centre for 10 visits over approximately 29 weeks.
  Patients will have blood and urine collected during study visits and 1 electrocardiogram (ECG) will be performed during the study.
  Patients will also be asked to self-monitor their blood sugar levels at home using a glucometer which will be provided.
  This is a multicentre study which will take place globally. It is anticipated that approximately 1048 patients will be asked to take part in the study and that 524 will take part in the treatment phase of this study at about 140 study clinics worldwide in up to 10 countries. It is expected that there will be 70 patients screened and 35 patients enrolled onto the study across 12 UK study centres.
  The study is being funded by Bristol-Myers Squibb.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  13/NW/0583

• Date of REC Opinion

  18 Nov 2013

• REC opinion

  Further Information Favourable Opinion