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NCT06619301RecruitingPhase 3

RCT Glargine vs NPH for Treatment of DM in Pregnancy

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
160 (estimated)
First submitted
25 Sept 2024
Start date
1 Apr 2024
Primary completion date
1 Apr 2026
Lead sponsor
Loyola University
NCT number
NCT06619301

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 160
  • From 1 Apr 2024 to the primary completion date, 1 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving insulin through an insulin pump

Other illness

  • Allergy to insulin
  • Has diagnosis of Type 1 Diabetes Mellitus

Age

  • Those under the age of 18 years old

Other

  • Those unable to consent in english
  • Controlled with only diet modification or the use of oral antihyperglycemics

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Loyola University Medical Center
Coordinator of this site? Confirm its status
MaywoodUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.