BIAJ - The IMAGINE 2 Study

• Research type

  Research Study

• Full title

  A Comparison of LY2605541 versus Insulin Glargine as Basal Insulin Treatment in Combination with Oral Anti-Hyperglycemia Medications in Insulin Naive Patients with Type 2 Diabetes Mellitus: A Double-Blind, Randomized Study: The IMAGINE 2 Study

• IRAS ID

  89691

• Contact name

  Jeffrey Stephens

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2011-000842-39

• ISRCTN Number

  1

• Research summary

  LY2605541 is a novel, long-acting basal insulin analogue (a type of drug that controls the glucose (sugar) levels in the blood of people with Diabetes). LY2605541 can be taken by patients with both Type 1 and Type 2 Diabetes. The drug is designed to act over a 24 hour period to maintain a flat blood glucose level in patients with Diabetes. Dose changes/increases are normally needed no more than every 5 days. This study will compare LY2605541 to insulin glargine (a marketed product) in insulin naive patients with Type 2 Diabetes who have failed at least 2 oral anti hyperglycaemic medications. All patients will be treated for 12 months and a subset of patients will be treated for 18 months. 189 patients out of the 1516 enrolled globally will also get the chance to participate in the Continuous Glucose Monitoring addendum to the study. This addendum aims to better understand the impact of LY2605541 on glucose metabolism as well as within and between patient variability in patients with Type 2 Diabetes. The addendum's particular focus will be the nocturnal period. 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

  Wales REC 1

• REC reference

  11/WA/0309

• Date of REC Opinion

  1 Feb 2012

• REC opinion

  Further Information Favourable Opinion