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RCT Glargine vs NPH for Treatment of DM in Pregnancy

NCT06619301 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-10-01

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus in Pregnancy
  • Type 2 Diabetes Mellitus (T2DM)
  • Gestational Diabetes Mellitus, Class A2

Interventions

DRUG

Insulin glargine

Insulin Glargine is regularly used outside of pregnancy and its efficacy is well documented. It is a current medication we regularly use in pregnancy, however, there is limited data for comparison to the standard, NPH.

DRUG

insulin NPH

Insulin NPH is a current medication used in pregnancy for diabetes mellitus. It has been used as the standard form of insulin.

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Principal Investigators

  • Joana Lopes Perdigao, MD · Loyola University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-04-01
Completion
2027-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06619301 on ClinicalTrials.gov