DETERMINE: Detemir vs NPH

Study Overview
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Brief Summary
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The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.

Detailed Description
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Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.

Official Title
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A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study

Conditions
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Gestational Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin Detemir
* Drug: Insulin NPH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy. Exclusion Criteria: Multiple Gestation Type 1 Diabetes mellatus Age < 18 Known or suspected hypersensitivity to NPH or insulin detemir Known fetal major malformations Chronic renal or hepatic insufficiency Known to be HIV, Hepatitis B, or Hepatitis C positive Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery) Insulin dependent before conception

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization to receive either insulin NPH or insulin detemir
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Detemir<br>Patients are to receive insulin detemir as long acting insulin to control blood sugars | Drug: Insulin Detemir<br>* Patients are to receive insulin detemir<br>|
| Active Comparator: Insulin NPH<br>Patients are to receive insulin NPH as long acting insulin to control blood sugars | Drug: Insulin NPH<br>* Patients are to receive insulin NPH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Hypoglycemia | Rate (%) of neonatal hypoglycemia | Within the first 24 hours of life | 
| Prolonged neonatal hypoglycemia | Rate (%) of prolonged neonatal hypoglycemia | Neonatal hypoglycemia after the 1st 24 hours of life but before discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Gastrin Level | Sample form cord blood | At birth | 
| Neonatal C-Peptide Level | Sample from cord blood | At birth | 
| Neonatal insulin level | Sample from cord blood | At birth | 
| Neonatal leptin level | Sample from cord blood | At birth | 
| Rates of pregnancy induced hypertension | Maternal rates of preeclampsia, eclampsia, or gestational hypertension | 1 year | 
| Mode of delivery | Spontaneous vaginal, operative vaginal, cesarean | At delivery | 
| Gestational Age at delivery | Gestational Age at delivery | At delivery | 
| Maternal glycemic control | Rate (%) of in range maternal blood glucose control in antepartum period | 1 year | 
| Total daily insulin | Total daily insulin dose in patient | 1 year | 
| Fetal anomolies | Rate (%) of fetal anomolies | At birth | 
| Macrosomia | Rate (%) of macrosomia | At birth | 
| Polyhydramnios | Rate (%) of polyhydramnios | At birth | 
| Neonatal weight | Neonatal weight | At birth | 
| Need for supplemental oxygen | Rate of supplemental oxygen use (%) in neonate | 1 year | 
| Need for dextrose infusion in neonate | Rate of dextrose infusion use (%) in neonate | 1 year | 
| Rates of respiratory distress syndrome | Rate of RDS (%) in neonate | 1 year | 
| 5 Minute APGAR | 5 Minute APGAR | At birth |