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
- Diseases
- Type 2 diabetes
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Loyola University Medical Center Coordinator of this site? Confirm its status | Maywood | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.