Type I DM Study

• Research type

  Research Study

• Full title

  Study 110933: Albiglutide versus Placebo in insulin-treated Subjects with new-onset type 1 diabetes mellitus

• IRAS ID

  159770

• Contact name

  Nicola Leech

• Contact email

  Nicola.Leech@nuth.nhs.uk

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2014-001825-33

• Research summary

  This is a GSK sponsored trial in subjects newly diagnosed with Type 1 diabetes mellitus. Subjects should be between 18 and 30 years old and have been diagnosed within 4 to 8 weeks prior to first dose.
  If subjects meet all eligibility criteria and wish to participate in the study, they will be randomised to one of the following treatment groups in a 3:1 ratio:
  - Albiglutide added-on to insulin therapy.
  - Placebo added-on to insulin therapy.
  Subjects will receive this treatment weekly for 52 weeks. They may stop the treatment if unacceptable side effects occur, or they are unable to continue the treatment, or they request to discontinue the study. They will be followed up for 12 weeks after treatment discontinuation for collection of long-term efficacy and safety data.
  The main objective is to determine if either of the treatment options above leads to a better glycaemic control (control of blood sugar) over the treatment duration. Additional objectives are evaluation of significant glycaemias, insulin dose and body weight differences between treatments. Safety and tolerability of albiglutide will also be evaluated.

  Approximately 68 subjects will be randomised, so 51 are assigned to albiglutide arm and 17 to placebo arm. Subject will be recruited in hospital clinics and will need to attend a set of visits, in which subjects will receive treatment, be examined, will be asked about general well-being and blood tests will be taken. They will also have calls with the study staff to review treatment and glycaemic control. Subjects participating in the study may be seen more frequently that those who do not. Study duration will be approximately 72 weeks. It is hoped that this study may contribute to further information regarding treatments with an effect on endogenous insulin production (the body’s own insulin) and the preservation of the cells involved in it.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  14/LO/1617

• Date of REC Opinion

  15 Oct 2014

• REC opinion

  Further Information Favourable Opinion