Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy

Diabetes Mellitus, Type 2 Clinical Trial

— Determin  

Official title:

Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy: a Comparative-effectiveness, Open Label, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620890
• Other study ID #: HSC-MS-18-0575
• Status: Completed
• Phase: Phase 4
• Start date: September 4, 2018
• Est. completion date: July 29, 2020

Study information

• Verified date: August 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 29, 2020
• Est. primary completion date: July 29, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Pregnancy in Diabetics

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Health Science Center of Houston	Houston	Texas

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fishel Bartal M, Ward C, Blackwell SC, Ashby Cornthwaite JA, Zhang C, Refuerzo JS, Pedroza C, Lee KH, Chauhan SP, Sibai BM. Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlle — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Neonates With Composite Adverse Neonatal Outcome	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	From the time of delivery to the time of discharge (about 2-14 days)
Secondary	Maternal Mean Fasting Glucose		perinatal to postpartum (32 weeks)
Secondary	Maternal Mean Post Prandial Glucose		perinatal to postpartum (32 weeks)
Secondary	Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy		perinatal to postpartum (32 weeks)
Secondary	Change in Maternal Weight During Pregnancy		perinatal to postpartum (32 weeks)
Secondary	Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy	Hypertensive disorder includes gestational hypertension, preeclampsia, or superimposed preeclampsia.	perinatal to postpartum (32 weeks)
Secondary	Number of Maternal Subjects Who Had Preeclampsia With Severe Features		perinatal to postpartum (32 weeks)
Secondary	Number of Subjects Who Had Cesarean Delivery		at delivery
Secondary	Number of Subjects Who Had Operative Vaginal Delivery		at delivery
Secondary	Gestational Weeks at Delivery		at delivery
Secondary	Number of Neonates Who Where Small for Gestational Age (SGA)	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.	at delivery
Secondary	Neonatal Hospital Admission Days		From the time of delivery to the time of discharge (about 2-14 days)
Secondary	# of Neonates Who Had 5-minute Apgar Score < 7	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.	5 minutes after delivery
Secondary	Number of Neonates Who Had Jaundice Requiring Therapy		From the time of delivery to the time of discharge (about 2-14 days)