Saxagliptin with metformin in paediatric type 2 diabetes patients
Research type
Research Study
Full title
A Multicentre, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in Paediatric Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Alone
IRAS ID
94808
Contact name
Timothy Barrett
Sponsor organisation
Bristol-Myers Squibb
Eudract number
2010-024568-16
Clinicaltrials.gov Identifier
Research summary
Diabetes is a long-term condition caused by too much glucose (sugar) in the blood. Normally, the amount of sugar in the blood is controlled by a hormone called insulin. When food is digested and enters the bloodstream, insulin helps to move the glucose out of the blood and into cells, where the body can break it down to energy. People with diabetes are unable to break down glucose into energy. Type 2 diabetes is when not enough insulin is produced for the body to function properly, or the body??s cells don??t react to the insulin. Type 2 diabetes is a complex disease, with contributions from aspects like diet, activity levels, family history, and race. Type 2 diabetes is becoming increasingly common in children as childhood obesity increases. It is expected that children and teenagers, like adults, with type 2 diabetes are at risk for developing diabetes-related diseases of the blood vessels. It is assumed that if blood sugar levels are managed by lifestyle and diet changes, activity levels, and medical treatment, the risks of complications in children and adults with the disease should be reduced. Current treatments have limited effects on blood sugar level regulation, and cause several side effects. Drugs that work in new ways (eg. Saxagliptin) are being studied with the aim to find drugs that are effective, and show fewer side effects. Since there is only one glucose lowering oral medication approved for children over 10 years of age, there is a need for more options. This study will compare saxagliptin to the approved drug (metformin) and a dummy-drug in children to establish how effective, safe and tolerable saxagliptin is. It is planned that approximately 236 participants will participate in this study. This study is sponsored by Bristol-Myers Squibb Research and Development.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
12/SC/0173
Date of REC Opinion
4 Apr 2012
REC opinion
Favourable Opinion