drugset / Trial / NCT01541215
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.
Timeline
- Start
- 2012-11-13
- Primary completion
- 2017-11-15
- Completion
- 2020-05-20
Publications
- Background Tamborlane WV, Barrientos-Perez M, Fainberg U, Frimer-Larsen H, Hafez M, Hale PM, Jalaludin MY, Kovarenko M, Libman I, Lynch JL, Rao P, Shehadeh N, Turan S, Weghuber D, Barrett T; Ellipse Trial Investigators. Liraglutide in Children and Adolescents with Type 2 Diabetes. N Engl J Med. 2019 Aug 15;381(7):637-646. doi: 10.1056/NEJMoa1903822. Epub 2019 Apr 28.
- Bensignor MO, Bomberg EM, Bramante CT, Divyalasya TVS, Hale PM, Ramesh CK, Rudser KD, Kelly AS. Effect of liraglutide treatment on body mass index and weight parameters in children and adolescents with type 2 diabetes: Post hoc analysis of the ellipse trial. Pediatr Obes. 2021 Aug;16(8):e12778. doi: 10.1111/ijpo.12778. Epub 2021 Feb 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Liraglutide | Peptide | 0.6 mg | Subcutaneous |
| Subject | Liraglutide | Peptide | 1.2 mg | Subcutaneous |
| Subject | Liraglutide | Peptide | 1.8 mg | Subcutaneous |
| Background | Metformin | Small molecule | 1000 mg | Oral |
| Background | Metformin | Small molecule | 2000 mg | Oral |