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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments Being Tested

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.

Locations (1)

Loyola University Medical Center
Maywood, Illinois, United States