Comparison of Lantus, Lixisenatide and Lixilan in Type 2 diabetes

• Research type

  Research Study

• Full title

  A randomized, 30 week, active-controlled, open-label, 3-treatment arm, parallel-group multicenter study comparing the efficacy and safety of insulin glargine/ lixisenatide fixed ratio combination to insulin glargine alone and to lixisenatide alone on top of metformin in patients with Type 2 diabetes mellitus

• IRAS ID

  142940

• Contact name

  Rory McCrimmon

• Contact email

  r.mccrimmon@dundee.ac.uk

• Sponsor organisation

  sanofi-aventis recherche & développement

• Eudract number

  2013-003131-30

• ISRCTN Number

  xx

• Clinicaltrials.gov Identifier

  xx

• Research summary

  This study is designed to compare the effectiveness and safety of three injectable diabetes medications, aimed to help people with Type 2 diabetes mellitus (T2DM) improve their diabetes control.
  It is very important for people with T2DM to maintain their blood sugar levels in the “normal” range (between 5 and 7 mmol/l) to try to prevent the onset of diabetes complications, such as eye, kidney and nerve and blood vessel disease. Often, people with diabetes struggle to get their blood sugar levels in this normal range with dieting exercise and oral medications.
  The purpose of this study is to evaluate, in people with T2DM, already taking metformin, the effectiveness and possible risks of Lixilan (insulin glargine/lixisenatide fixed ratio combination) self-injected once daily up to one hour before breakfast compared with its components:
  • Lantus® (insulin glargine self-injected under the skin once daily alone) and
  • Lixisenatide (GLP-1 receptor agonist, self-injected once daily alone, either one hour before breakfast, or dinner)
  Before the Study starts, the study doctor will take a full medical history, examine the participant and arrange some tests. If there are no problems, the participant will enter a run-in period lasting 4 weeks. If certain pre-specified criteria are met during screening and run-in, participants will enter a 30 week treatment period and will be assigned to one of the three treatment groups:
  1. Lixilan (insulin glargine / lixisenatide fixed ratio combination)
  2. Lantus® (insulin glargine)
  3. Lixisenatide (Lyxumia®, GLP-1 receptor agonist)
  The duration of the Study is approximately 37 weeks and comprises 4 periods:
  • A 2-week screening period
  • A 4-week run-in period
  • A 30-week treatment period
  • A follow up period lasting approximately 3 days following completion of treatment

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  13/LO/1911

• Date of REC Opinion

  22 Jan 2014

• REC opinion

  Further Information Favourable Opinion