The IMAGINE 4 Study

• Research type

  Research Study

• Full title

  Protocol I2R-MC-BIAM: The Impact of LY2605541 versus Insulin Glargine for Patients with Type 2 Diabetes Mellitus Advanced to Multiple Injection Bolus Insulin with Insulin Lispro: a Double-Blind, Randomized, 26-week Study: The IMAGINE 4 Study

• IRAS ID

  100840

• Contact name

  Melanie Davies

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2011-001254-29

• ISRCTN Number

  xx

• Research summary

  Type 2 diabetes develops when the body does not make enough insulin and/or the body does not use the insulin properly. This can lead to increased blood sugar levels, which, if not treated, can cause serious damage to all organ systems in the body. Many people with type 2 diabetes are able to control their symptoms through lifestyle factors such as eating a healthy diet exercise. However, as type 2 diabetes is a progressive condition, some people may eventually need to take insulin medication. LY2605541 is a new long-acting 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 participants (1,325 worldwide, 30 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 mealtimes. Participants will receive treatment for 26 weeks (either the new drug or standard treatment) and will be required to monitor their blood sugar levels daily. Participants will undergo regular blood tests and monitoring of their own blood sugar levels using electronic diaries. Study procedures will include: ECGs, regular fasting and non fasting blood tests, urine tests, questionnaire and diary completion, self administration of study drug and monitoring of blood glucose levels and physical examinations.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  12/LO/0301

• Date of REC Opinion

  10 Jul 2012

• REC opinion

  Further Information Favourable Opinion