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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient requiring initiation of insulin therapy for Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus in pregnancy

• At least 18 years old

• Insulin started prior to 34 weeks gestation

• Established prenatal care by 14 weeks gestation

Locations
United States
Illinois
Loyola University Medical Center
RECRUITING
Maywood
Contact Information
Primary
Joana Lopes Perdigao, MD
joana.perdigao@lumc.edu
708-216-4033
Backup
Nuong Truong, MD
nuong.t.truong@luhs.org
708-216-4033
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 160
Treatments
Active_comparator: Insulin Glargine
Insulin Glargine dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.
Active_comparator: Insulin NPH
Insulin NPH dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.
Sponsors
Leads: Loyola University

This content was sourced from clinicaltrials.gov