The IMAGINE 3 Study

• Research type

  Research Study

• Full title

  Protocol I2R-MC-BIAO The Impact of LY2605541 versus Insulin Glargine for Patients with Type 1 Diabetes Mellitus Treated with Preprandial Insulin Lispro: a Double-Blind, Randomized, 52 Week Study The IMAGINE 3 Study

• IRAS ID

  90653

• Contact name

  David Russell-Jones

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2011-001253-82

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Type 1 diabetes develops when the body's immune system attacks and destroys the cells that produce insulin. As a result the body is unable to produce insulin, leading to increased blood sugar levels, which in turn can cause serious damage to all organ systems in the body. LY2605541 is a new insulin drug that has been shown (in a study using a small number of patients) to be more effective than insulin glargine (a frequently prescribed standard treatment) at maintaining steady blood sugar levels during the course of the day, this reduces the need for more than one daily dose. This study will use a larger number of patients (1,113 worldwide, 47 in the UK) to confirm whether LY2605541 is more effective at controlling blood sugar levels compared to insulin glargine, when both are administered with a fast-acting insulin taken just before meal-times. Patients will receive treatment for 52 weeks (either the new drug or standard treatment) and will be required to monitor their blood sugar levels daily. Patients will undergo regular blood tests and monitoring of their own blood sugar levels.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/SC/0485

• Date of REC Opinion

  3 Jan 2012

• REC opinion

  Further Information Favourable Opinion