Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes

• Research type

  Research Study

• Full title

  A Phase IIb, double-blind, parallel group, multi-centre, dose-finding study to investigate the efficacy and safety of 4 doses of MP-513 when added to ongoing metformin monotherapy in subjects with Type 2 diabetes mellitus, with an open label extension

• IRAS ID

  22472

• Sponsor organisation

  Mitsbishi Tanabe Pharma Corporaton

• Eudract number

  2008-008732-84

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The purpose of this research study is to determine the safety and effectiveness of an investigational drug called MP-513 for treating patients with type 2 diabetes, when added to metformin treatment. Studies completed in the laboratory and in animals indicate that MP-513 may improve diabetes control in humans and has a favourable safety profile. Patients will be randomised to receive one of four different doses of MP-513 or placebo in addition to their regular metformin therapy for 24 weeks. As this part of the study is double blind neither the doctor or patient will know what treatment they are receiving. Patients who have completed the double blind period will then continue into the open label extension where they will receive 20 mg of MP-513 for 28 weeks in addition to their regular metformin therapy. Approximately 400 patients will take part in the study from centres all over Europe. In the UK, approximately 42 patients will take part in the study.The total duration of the study is approximately 1 year during which patients will attend regular follow up visits. Study procedures will include complete physical and body skin examination, vital signs including weight and height, blood and urine sampling, pregnancy test, concomitant medications, ECG, glucose self monitoring and adverse event reporting.The use of drugs intended to treat obesity and any antidiabetic treatment (apart from metformin) is prohibited while patients are on study drug. An independent data monitoring committee Board (DSMB) will monitor the safety on a regular basis during the study to ensure timely recognition of previously unknown risks to patients.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  09/H0504/74

• Date of REC Opinion

  25 Sep 2009

• REC opinion

  Further Information Favourable Opinion