Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes

Phase 4 Completed 457 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Asia, South America and the United States of America (USA). The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).

Timeline

Start: 2009-05
Primary completion: 2010-06
Completion: 2010-06

Outcome

Missed primary endpoint

paper Non-inferiority for detemir at the a priori level of 0.4%-points was not established. PMID 23421331 ↗

Publications

Results Meneghini L, Kesavadev J, Demissie M, Nazeri A, Hollander P. Once-daily initiation of basal insulin as add-on to metformin: a 26-week, randomized, treat-to-target trial comparing insulin detemir with insulin glargine in patients with type 2 diabetes. Diabetes Obes Metab. 2013 Aug;15(8):729-36. doi: 10.1111/dom.12083. Epub 2013 Mar 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin detemir	Protein / enzyme biologic	—	Subcutaneous
Comparator	insulin glargine	Protein / enzyme biologic	—	Subcutaneous