ITSB; LY900014 vs Humalog for children/adolescents with T1 Diabetes
Research type
Research Study
Full title
I8B-MC-ITSB; A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog with an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents with Type 1 Diabetes PRONTO-Peds
IRAS ID
255691
Contact name
Ursula Ngwu
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2018-002371-18
Duration of Study in the UK
1 years, 9 months, 26 days
Research summary
Summary of Research
Normally, the body breaks down sugars and starches that are eaten into a simple sugar called glucose, which is used for energy. Insulin is a hormone that the body needs to get glucose from the bloodstream into the cells of the body. In type 1 diabetes, the body does not produce insulin. People with type 1 diabetes must be treated with insulin therapy by injections or a pump.
Blood glucose (sugar) levels increase quickly after meals. Injecting insulin at mealtime can help to control this rise in blood sugar. This study will look at how LY900014, an investigational, mealtime, ultra-rapid insulin lispro formulation affects the blood glucose (sugar) levels of children and adolescents with type 1 diabetes compared with another mealtime insulin, Humalog.
Approximately 708 patients, aged between 1 and 18 years old, will participate in this study from centres around the world. Patients will be randomized to receive treatment with either LY900014 or Humalog. Two treatment groups will receive either LY900014 or Humalog before a meal and neither the patients nor their doctors will know which type of insulin these groups are receiving. A third group will receive LY900014 up to 20 minutes after starting a meal; this group and the study doctor will know the insulin they are receiving due to a difference in injection time. Patients will remain on their current long-acting insulin and will receive their allocated medication for 26 weeks.
Upon completion of the study treatment period, the study doctor will discuss the insulin treatment options available to participants and their health will be monitored for 2 weeks.
Summary of Results
A Lay Summary has not been created yet, but will be provided when available.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0045
Date of REC Opinion
9 Apr 2019
REC opinion
Further Information Favourable Opinion