drugset / Trial / NCT01573286
Safety and Dosing Study of Glucagon-like Peptide 2 (GLP-2) in Infants and Children With Intestinal Failure
Phase 1/2
Terminated
13 enrolled
Alberta Children's Hospital
British Columbia Children's Hospital · collabStollery Children's Hospital · collabThe Hospital for Sick Children · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This protocol outlines a randomized,open label trial examining the safety, pharmacology and efficacy of Glucagon like peptide 2 (GLP-2) in infants and children with intestinal failure. The investigators hypothesize that GLP-2 given subcutaneously in these patients will be well tolerated, and have similar metabolism to what has been shown in adults. The investigators also expect to show an improvement in the tolerance of enteral nutrition, and a decreased requirement for intravenous feeding.
Timeline
- Start
- 2012-01
- Primary completion
- 2014-08
- Completion
- 2015-08
Publications
- Background Sigalet DL, de Heuvel E, Wallace L, Bulloch E, Turner J, Wales PW, Nation P, Wizzard PR, Hartmann B, Assad M, Holst JJ. Effects of chronic glucagon-like peptide-2 therapy during weaning in neonatal pigs. Regul Pept. 2014 Jan 10;188:70-80. doi: 10.1016/j.regpep.2013.12.006. Epub 2013 Dec 22.
- Results Sigalet DL, Lam V, Karnik V, Brindle M, Boctor D, Casey LW, Dicken B, Butterworth S, Stoffman S,de Heuval E, Wright-wilson G, Wallace L. Safety and Dosing Study of Glucagon-like Peptide 2 (GLP-2) in Children With Intestinal Failure DDW Abstract presented at DDW 2014, Chicago IL
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GLUCAGON-LIKE PEPTIDE II | Peptide | 5 ug/kg | Subcutaneous |
| Subject | GLUCAGON-LIKE PEPTIDE II | Peptide | 10 ug/kg | Subcutaneous |
| Subject | GLUCAGON-LIKE PEPTIDE II | Peptide | 20 ug/kg | Subcutaneous |