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Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up Women only

Comparing two types of insulin for managing diabetes in pregnancy

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

Run by Loyola University · NCT06619301 · Data updated 2026-11-12

This study tests whether Glargine insulin works just as well as NPH insulin for managing diabetes in pregnant women who need insulin therapy.

More Type 2 Diabetes Mellitus (T2DM) trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment160 (estimated)
SponsorLoyola University
Academic / other
Locations1 site (Maywood, Illinois)
StatusRecruiting
StartedApril 1, 2024
Main results expectedApril 1, 2026
Study endsJanuary 1, 2027
Registry record updatedOctober 1, 2024
Trial IDNCT06619301 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are pregnant women aged 18 and older who require insulin therapy for Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Loyola University Medical Center
    Maywood, Illinois, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.