Recruiting PHASE3 Diabetes Mellitus in Pregnancy

Compares treatment options for Diabetes Mellitus in Pregnancy

Official title RCT Glargine vs NPH for Treatment of DM in Pregnancy

ClinicalTrials.gov ID: NCT06619301

What this study is testing

What is Insulin glargine?

Insulin glargine is an investigational medicine, being studied as a potential treatment for diabetes mellitus in pregnancy.

Also referred to as Lantus, Toujeo.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, women only

You may be able to join if

  • 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

You likely can't join if

  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Maywood, Illinois, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Maywood, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.