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RECRUITING
NCT06619301
PHASE3

RCT Glargine vs NPH for Treatment of DM in Pregnancy

Sponsor: Loyola University

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Controlled Trial of Glargine Versus Neutral Protamine Hagedorn Insulin for the Treatment of Diabetes Mellitus in Pregnancy

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2024-04-01

Completion Date

2027-01-01

Last Updated

2024-10-01

Healthy Volunteers

No

Interventions

DRUG

Insulin glargine

Insulin Glargine is regularly used outside of pregnancy and its efficacy is well documented. It is a current medication we regularly use in pregnancy, however, there is limited data for comparison to the standard, NPH.

DRUG

insulin NPH

Insulin NPH is a current medication used in pregnancy for diabetes mellitus. It has been used as the standard form of insulin.

Locations (1)

Loyola University Medical Center

Maywood, Illinois, United States