Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)

Phase 4 Completed 74 enrolled Emory University Sanofi · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The study is a multicenter, randomized controlled trial to compare the safety and efficacy of insulin analogs and human insulins both during acute intravenous treatment and during the transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).

Timeline

Start: 2007-12
Primary completion: 2008-06
Completion: 2008-08

Publications

Results Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Ceron M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Insulin	Protein / enzyme biologic	—	Intravenous
Subject	Insulin glulisine	Protein / enzyme biologic	—	Intravenous
Comparator	Intermediate acting Insulin (NPH)	Unknown	—	Subcutaneous
Subject	insulin glargine	Protein / enzyme biologic	—	Subcutaneous

Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)

Summary

Timeline

Publications

Drugs

Indications