NCT06619301 RCT Glargine vs NPH for Treatment of DM in Pregnancy
| NCT ID | NCT06619301 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Loyola University |
| Condition | Diabetes Mellitus in Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2024-04-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Joana Lopes Perdigao, MD
PRINCIPAL INVESTIGATOR
Loyola University
Frequently Asked Questions
Who can join the NCT06619301 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Diabetes Mellitus in Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06619301 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT06619301 currently recruiting?
Yes, NCT06619301 is actively recruiting participants. Contact the research team at joana.perdigao@lumc.edu for enrollment information.
Where is the NCT06619301 trial being conducted?
This trial is being conducted at Maywood, United States.
Who is sponsoring the NCT06619301 clinical trial?
NCT06619301 is sponsored by Loyola University. The principal investigator is Joana Lopes Perdigao, MD at Loyola University. The trial plans to enroll 160 participants.
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.