SENIOR

• Research type

  Research Study

• Full title

  A Randomized, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-U300 Versus Lantus in Older Patients with Type 2 Diabetes Inadequately Controlled on Antidiabetic Regimens Either Including no Insulin, or with Basal Insulin as Their Only Insulin

• IRAS ID

  168188

• Contact name

  Benjamin Christopher Thomas Field

• Contact email

  Benjamin.Field@sash.nhs.uk

• Sponsor organisation

  Sanofi-aventis recherche & développement

• Eudract number

  2014-002399-10

• Clinicaltrials.gov Identifier

  NCT02320721

• Duration of Study in the UK

  1 years, 11 months, 18 days

• Research summary

  The purpose of this study is to evaluate the possible risks and the effectiveness of a newly developed, more concentrated formulation of insulin glargine (HOE900-U300) with the approved formulation of insulin glargine (Lantus) in the treatment of older patients ((= 65) with type 2 diabetes inadequately controlled on anti-diabetic regimens.

  Lantus is a long-acting human insulin analogue. An insulin analogue is similar to human insulin, however with a different chemical structure. With Lantus this changed structure leads to an extended duration of glucose-lowering activity of approximately 24-hour period. Lantus has been registered since June 2000 in Europe.

  A formulation, HOE901-U300, containing 300 U of insulin glargine per mL is under development for adult patients with diabetes mellitus where treatment with insulin is required. HOE901-U300 has the same composition as the current 100 U/mL insulin glargine (Lantus U100) formulation with adjustment of 3-times the amount of active pharmaceutical ingredient glargine) and corresponding zinc content. HOE901-U300 would offer patients the opportunity to administer their basal insulin at a reduced injection volume. The results confirm HOE901-U300 to be well suitable for constant 24-hour basal insulin supply, with the expectation of less hypoglycaemic risk at equal to tighter blood glucose control as compared to Lantus. HOE901-U300 has not been approved by health authorities for commercial use.

  A total of approximately 920 patients (about 460 in each treatment group) with type 2 diabetes will participate in this study.

  This study has 3 periods and 21 visits (10 on-site visits and 11 phone call visits):
  1. A 4-week screening period
  2. A 26-week open-label treatment period: treatment with H0E901-U300 or Lantus in addition to background non-insulin anti-diabetic drugs if appropriate,
  3. A 2-day safety follow-up period

  The total participation in this study will be approximately 30 weeks plus 2 days.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  15/NW/0156

• Date of REC Opinion

  14 Apr 2015

• REC opinion

  Further Information Favourable Opinion