Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy

Summary

The aim of this study is to compare glycemic control in pregnant women treated with insulin Detemir and pregnant women treated with NPH insulin. These women are diagnosed with gestational diabetes (GDM) in the current pregnancy or have a preexisting diagnosis of type 2 diabetes (T2DM) at the onset of pregnancy. Our hypothesis is that there is no difference between these two treatment modalities in terms of glycemic control in diabetes.

Timeline

Start

2013-03

Primary completion

2015-03

Completion

2015-03

Outcome

Met primary endpoint

paper The difference in the mean BG of the groups was 2.1 mg/dL with a 1-sided upper 95% confidence limit of 5.5 mg/dL (less than the PMID 26070699 ↗

paper 5.5 mg/dL (less than the maximal acceptable difference of 7 mg/dL; P = .2937). PMID 26070699 ↗

Publications

• Herrera KM, Rosenn BM, Foroutan J, Bimson BE, Al Ibraheemi Z, Moshier EL, Brustman LE. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol. 2015 Sep;213(3):426.e1-7. doi: 10.1016/j.ajog.2015.06.010. Epub 2015 Jun 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin detemir	Protein / enzyme biologic	—	—
Subject	insulin neutral protamine Hagedorn	Unknown	—	—

Indications