drugset / Trial / NCT00662714
Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis
Phase 3
Completed
73 enrolled
Mukoviszidose Institut gGmbH
Assistance Publique - Hôpitaux de Paris · collabMucoviscidose-ABCF2 · collabNovo Nordisk A/S · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the phase III trial.
Timeline
- Start
- 2001-09
- Primary completion
- 2011-12
- Completion
- 2011-12
Publications
- Onady GM, Stolfi A. Drug treatments for managing cystic fibrosis-related diabetes. Cochrane Database Syst Rev. 2020 Oct 19;10(10):CD004730. doi: 10.1002/14651858.CD004730.pub5.
- Ballmann M, Hubert D, Assael BM, Staab D, Hebestreit A, Naehrlich L, Nickolay T, Prinz N, Holl RW; CFRD Study Group. Repaglinide versus insulin for newly diagnosed diabetes in patients with cystic fibrosis: a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018 Feb;6(2):114-121. doi: 10.1016/S2213-8587(17)30400-X. Epub 2017 Dec 5.
- Ballmann M, Hubert D, Assael BM, Kronfeld K, Honer M, Holl RW; CFRD Study group. Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus. BMC Pediatr. 2014 Mar 11;14:70. doi: 10.1186/1471-2431-14-70.
- Schmid K, Fink K, Holl RW, Hebestreit H, Ballmann M. Predictors for future cystic fibrosis-related diabetes by oral glucose tolerance test. J Cyst Fibros. 2014 Jan;13(1):80-5. doi: 10.1016/j.jcf.2013.06.001. Epub 2013 Jun 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin | Protein / enzyme biologic | 0.05 iu/kg | Other |
| Subject | Repaglinide | Small molecule | 0.5 mg | Oral |