RCT Glargine vs NPH for Treatment of DM in Pregnancy

We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH. The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.

NCT Number	NCT06619301
Lead Sponsor	Loyola University
Conditions	Diabetes Mellitus in Pregnancy, Type 2 Diabetes Mellitus (T2DM), Gestational Diabetes Mellitus, Class A2
Enrollment	160 participants
Start Date	2024-04-01
Primary Completion	2026-04-01 (estimated)
Study Completion	2027-01-01 (estimated)
Updated on ClinicalTrials.gov	2024-10-01