RCT Glargine vs NPH for Treatment of DM in Pregnancy

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLoyola University

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Insulin glargine
  • insulin NPH

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators