Novo Type 2 - NN2211-3659: Efficacy and safety of liraglutide in combination with metformin versus metformin monotherapy on glycaemic control in children and adolescents with type 2 diabetes (IRB# 41342)
- Principal Investigator: Ying Tai Chang, MD, MPH
Insulin is necessary for the body to be able to use sugar. People with type 2 diabetes have a reduced ability to use sugar and to maintain a normal sugar level in the blood. The use of sugar and the regulation of the blood sugar level can become so poor that an oral (OAD) or injectable anti-diabetic drug is needed.
In the past, type 2 diabetes was considered a disease of adults and older individuals, not a disease of children. Over the last decade however there have been an increasing number of cases of type 2 diabetes mellitus in adolescents, mirroring increasing rates of obesity. At the time of planning the present trial the only non-insulin diabetes treatment approved for use in children and adolescents is metformin.
The purpose of this trial is to compare the blood sugar lowering effect and the safety of liraglutide (study drug) and liraglutide placebo (no active drug) when it is given together with metformin treatment in children and adolescents (10-16 years) with type 2 diabetes. This will tell us if liraglutide is effective and safe to use in children and adolescents.
-Informed consent from a legally acceptable representative (LAR) and child assent from the subject must be obtained before any trial-related activities
-Children and adolescents between the ages of 10–16 years. Subjects cannot turn 17 and 11
months before the end of treatment (52 weeks)
-Diagnosis of type 2 diabetes mellitus and treated for at least 90 days with diet and exercise alone, or diet and exercise in combination with metformin monotherapy.
- >=7.0% and <=11% if diet and exercise treated
- >=6.5% and <=11% if treated with metformin
-BMI >85th percentile of the general age and gender matched population (see Appendix A of protocol)
Additional Study Details:
If you and your child decide to take part in this research trial and sign this informed consent and the child assent form, the trial site staff will invite you to the screening visit to determine your child's eligibility for participation in the trial. Your child will have to attend the screening visit fasting (having been fasting for at least 8 hours before the visit). During the visit the trial site staff will interview and assess your child in order to find out if your child meets the criteria for participating in the trial.
Penn State Milton S. Hershey Medical Center
Pediatric Clinical Research Office