Diabetes Therapy to Improve BMI and Lung Function in CF

Phase 3 Completed 108 enrolled National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Cystic Fibrosis Foundation · collab Novo Nordisk A/S · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).

Timeline

Start: 2001-06
Primary completion: 2007-12
Completion: 2007-12

Publications

Results Moran A, Pekow P, Grover P, Zorn M, Slovis B, Pilewski J, Tullis E, Liou TG, Allen H; Cystic Fibrosis Related Diabetes Therapy Study Group. Insulin therapy to improve BMI in cystic fibrosis-related diabetes without fasting hyperglycemia: results of the cystic fibrosis related diabetes therapy trial. Diabetes Care. 2009 Oct;32(10):1783-8. doi: 10.2337/dc09-0585. Epub 2009 Jul 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Repaglinide	Small molecule	0.5 mg	Oral
Comparator	insulin aspart	Protein / enzyme biologic	0.5 iu	—

Diabetes Therapy to Improve BMI and Lung Function in CF

Summary

Timeline

Publications

Drugs

Indications