AVE0010-EFC12626 (Lixisenatide): Version 1.0

• Research type

  Research Study

• Full title

  A randomized, open-label, active-controlled, 3-arm parallel-group, 26-week study comparing the efficacy and safety of lixisenatide to that of insulin glulisine once daily and insulin glulisine three times daily in patients with Type 2 diabetes insufficiently controlled with insulin glargine with or without metformin.

• IRAS ID

  118404

• Contact name

  Simon Heller

• Sponsor organisation

  Sanofi

• Eudract number

  2012-004096-38

• Clinicaltrials.gov Identifier

  NCT01768559

• Research summary

  The progressive nature of type 2 diabetes mellitus (T2DM) means that a significant number of patients will eventually require an insulin-based therapy to control their blood sugar. Very often, the insulin treatment starts with basal insulin (such as insulin glargine (Lantus®)) which acts mainly on fasting blood sugar. However, when basal insulin is no longer sufficient, it seems logical to add to basal insulin treatments, new insulin that acts mainly on blood sugar after meals. This study will compare the effectiveness and safety of the addition to Lantus® of two of these treatments: Lixisenatide or Insulin Glulisine (Apidra®). Lixisenatide will be self-injected once daily before breakfast or dinner. Apidra® will be self-injected either once daily before breakfast or dinner or three times a day before each meal. Lixisenatide and Apidra® will be given in combination with Lantus® and Metformin (if this was already being taken prior to the study).The duration of the study is approximately 41 weeks and comprises 3 periods of up to 14 weeks in screening, 26 weeks treatment and a follow-up visit conducted by telephone 3 days after the end of treatment visit.At the end of the screening period, patients whose HbA1c level is above or equal to 7% and less than or equal to 9% and whose fasting blood sugar is less than or equal to 140 mg/dl (7.8 mmol/l) are eligible to enter the 26-week treatment period. Patients not reaching the goal cannot enter the treatment period and will stop their study participation.In the treatment period eligible patients will be assigned by chance (like the flip of a coin) to one of the three treatment groups: Lixisenatide or Apidra® once or 3-times a day (added to Lantus® with or without Metformin).There is also a Sub-Study and a Pharmacogenetic Sub-Study with further details provided in section A13.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  13/NE/0080

• Date of REC Opinion

  8 Apr 2013

• REC opinion

  Further Information Favourable Opinion