NN2211-3659 Efficacy and safety of liraglutide in combination with metformin versus metformin monotherapy on glycemic control in children and adolescents with type 2 diabetes [?] A 26-week double-blind, randomised, parallel group, placebo controlled multi-centre trial followed by a 26-week open-label extension

Study ID
STU 102012-036

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas

Contact
Julie Long
214-456-5136
julie.long@childrens.com

Principal Investigator
Ximena Lopez

Summary

This is a multi-center, 26-week randomised double-blind, parallel-group, placebo-controlled clinical
trial followed by a 26-week open-label extension in subject's ages 10x17 years with type 2 diabetes.
after being titrated to 2000 mg of metformin or maximum tolerated dose (MTD) equal to or greater than 1000 mg, subjects will be randomised 1:1 to receive liraglutide (1.8 mg or MTD) or placebo.

after 26 weeks of blinded treatment, the treatment allocation will be unblinded. Subjects treated
with liraglutide will continue their trial medication until end of treatment. Subjects treated with placebo
will discontinue their placebo treatment. Rescue treatment will be allowed for subjects in both treatment groups experiencing confirmed hyperglycemia. if it is during the blinded treatment period, the treatment allocation will be unblinded prior to initiating rescue treatment.Subjects on rescue medication will stay in the trial.
Subjects treated with liraglutide for more than 3 months will complete 1 and 2 year follow-up visits.

Primary endpoint
-Change in Hba1c (measurement of blood glucose control over an extended time) from baseline to week 26

Key secondary objectives
To assess and compare the effect of liraglutide in combination with metformin versus metformin
alone on:
- Parameters of glycaemic control
- Safety and tolerability

Key secondary endpoints
at 26 and 52 weeks of treatment:
- Hba1c [Less Than]7.0% (yes/no)
- Hba1c [LessThanorequalTo]6.5% (yes/no)
-Hba1c [Less Than]7.0% without severe or minor hypoglycemic episodes (yes/no)
Change from baseline at 26 and 52 weeks of treatment in:
-Fasting plasma glucose (FPG)
-7-point self-measured plasma glucose
-Body weight
-BMi standard deviation score (SDS)


Participant Eligibility

1. Informed consent from a legally acceptable representative (LAR) and child assent from the
subject must be obtained before any trial-related activities.
2. Children and adolescents between the ages of 10x16 years. Subjects cannot turn 17 and 11
months before the end of treatment (52 weeks)
3. 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.
4. HbA1c
- equal or greater than 7.0% and equal or less than 11% if diet and exercise treated
- equal or greater than 6.5% and equal or less than 11% if treated with metformin
5. BMI >85th percentile of the general age and gender matched population