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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Insulin glargine

    Drug

    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.

  • insulin NPH

    Drug

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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Insulin GlargineActive comparator 1 intervention
Group B: Insulin NPHActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hypoglycemia

Episodes of hypoglycemia with blood glucose less than 60 mg/dL

Time frame
From initiation of insulin therapy to delivery

Secondary outcomes

1

Large for Gestational Age

Birth weight greater than or equal to the 90th percentile for gestational age

Time frame
At delivery
2

Shoulder dystocia

Diagnosed by delivering providing

Time frame
At delivery

Other outcomes

Sponsors and contacts

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