Comparing two types of insulin for managing diabetes in pregnancy
Randomized Controlled Trial of Glargine Versus Neutral Protamine Hagedorn Insulin for the Treatment of Diabetes Mellitus in Pregnancy
This study tests whether Glargine insulin works just as well as NPH insulin for managing diabetes in pregnant women who need insulin therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Loyola University Academic / other |
| Locations | 1 site (Maywood, Illinois) |
| Trial ID | NCT06619301 on ClinicalTrials.gov |
What this trial studies
This research compares the effectiveness of two insulin types, Glargine and NPH, for managing diabetes mellitus in pregnant patients. It is an open-label, noninferiority, prospective randomized study involving patients diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy. Participants will be randomly assigned to receive either Glargine or NPH insulin, with a focus on monitoring hypoglycemia as the primary outcome. Patients will also receive education on insulin use and dietary management throughout the study.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older who require insulin therapy for Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus.
Not a fit: Patients who are under 18, have Type 1 Diabetes Mellitus, or are controlled with diet or oral medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer insulin management options for pregnant women with diabetes, potentially reducing hypoglycemia incidents.
How similar studies have performed: While other studies have explored insulin management in pregnancy, the specific comparison of Glargine and NPH is less well-studied, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Those under the age of 18 years old * Those unable to consent in english * Allergy to insulin * Controlled with only diet modification or the use of oral antihyperglycemics * Has diagnosis of Type 1 Diabetes Mellitus * Receiving insulin through an insulin pump
Where this trial is running
Maywood, Illinois
- Loyola University Medical Center — Maywood, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Joana Lopes Perdigao, MD — Loyola University
- Study coordinator: Joana Lopes Perdigao, MD
- Email: joana.perdigao@lumc.edu
- Phone: 708-216-4033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.