Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Neutral Protamine Hagedorn (NPH)
Drug: Detemir insulin

Registration Number: NCT03620890

Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary: To determine whether use of detemir compared to neutral protamine hagedorn (NPH) decreases rates of composite neonatal outcome and maternal hypoglycemia events in women with Type 2 Diabetes Mellitus (T2DM).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 108

Inclusion Criteria

Preexisting type 2 diabetes mellitus requiring medical treatment or
overt diabetes diagnosed prior to 20 weeks of gestation using either Hemoglobin A1c (HBA1C) ≥ 6.5 or fasting glucose ≥126 mg/dl or random blood glucose ≥ 200 mg/dl or two step method ( 50g glucose challenge test (GCT) >135 mg/dl followed by 100 GCT with at least 2 values above thresholds: Fasting Blood Glucose (FBG) >90, 1 hr >180, 2 hr > 155, 3 hr > 140 mg/dl).
Gestational age ≤20 weeks
Willing to start insulin therapy or to continue insulin treatment during pregnancy
Singleton or twin pregnancy

Exclusion Criteria

Known allergy/prior adverse reaction to NPH/detemir
Patients <18y
Known major fetal anomalies
Diabetic nephropathy (Creatinine (Cr)≥1.5)
Diabetic proliferative retinopathy
Patients with Type 1 diabetes or gestational diabetes

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neutral Protamine Hagedorn (NPH)	Neutral Protamine Hagedorn (NPH)	NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
Detemir	Detemir insulin	Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)

Primary Outcome Measures

Name	Time	Method
Number of Neonates With Composite Adverse Neonatal Outcome	From the time of delivery to the time of discharge (about 2-14 days)	Composite Adverse Neonatal Outcome includes 1 or more of any of the following: * Neonatal intensive care unit (NICU) admission or * Neonatal hypoglycemia (\<40 mg/dL in the first 24 hours of life and less than 50 mg/dL after) or requiring medical therapy or * Respiratory distress (need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life or * Shoulder dystocia - defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head in order to deliver the fetal body after the fetal head has been delivered or * Large for gestational age (LGA) -weight over 90th percentile of the expected value according to gestational age or * Macrosomia- Fetal weight above 4000g

Secondary Outcome Measures

Name	Time	Method
Maternal Mean Post Prandial Glucose	perinatal to postpartum (32 weeks)
Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy	perinatal to postpartum (32 weeks)
Number of Subjects Who Had Cesarean Delivery	at delivery
Number of Neonates Who Where Small for Gestational Age (SGA)	at delivery	Small for gestational age (SGA) means that a fetus or an infant is smaller or less developed than normal for the baby's sex and gestational age. Small for gestational age (SGA) is defined as a birth weight that is below the 10th percentile.
Neonatal Hospital Admission Days	From the time of delivery to the time of discharge (about 2-14 days)
Change in Maternal Weight During Pregnancy	perinatal to postpartum (32 weeks)
Gestational Weeks at Delivery	at delivery
Maternal Mean Fasting Glucose	perinatal to postpartum (32 weeks)
Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy	perinatal to postpartum (32 weeks)	Hypertensive disorder includes gestational hypertension, preeclampsia, or superimposed preeclampsia.
Number of Subjects Who Had Operative Vaginal Delivery	at delivery
Number of Neonates Who Had Jaundice Requiring Therapy	From the time of delivery to the time of discharge (about 2-14 days)
Number of Maternal Subjects Who Had Preeclampsia With Severe Features	perinatal to postpartum (32 weeks)
# of Neonates Who Had 5-minute Apgar Score < 7	5 minutes after delivery	The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.