Clinical trial NCT03620890: Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
Official title: Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy: a Comparative-effectiveness, Open Label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Pregnancy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Neonates With Composite Adverse Neonatal Outcome
timeFrame: From the time of delivery to the time of discharge (about 2-14 days)
Secondary outcomes:
measure: Maternal Mean Fasting Glucose
timeFrame: perinatal to postpartum (32 weeks)
measure: Maternal Mean Post Prandial Glucose
timeFrame: perinatal to postpartum (32 weeks)
measure: Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy
timeFrame: perinatal to postpartum (32 weeks)
measure: Change in Maternal Weight During Pregnancy
timeFrame: perinatal to postpartum (32 weeks)
measure: Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy
timeFrame: perinatal to postpartum (32 weeks)
measure: Number of Maternal Subjects Who Had Preeclampsia With Severe Features
timeFrame: perinatal to postpartum (32 weeks)
measure: Number of Subjects Who Had Cesarean Delivery
timeFrame: at delivery
measure: Number of Subjects Who Had Operative Vaginal Delivery
timeFrame: at delivery
measure: Gestational Weeks at Delivery
timeFrame: at delivery
measure: Number of Neonates Who Where Small for Gestational Age (SGA)
timeFrame: at delivery
measure: Neonatal Hospital Admission Days
timeFrame: From the time of delivery to the time of discharge (about 2-14 days)
measure: # of Neonates Who Had 5-minute Apgar Score < 7
timeFrame: 5 minutes after delivery
measure: Number of Neonates Who Had Jaundice Requiring Therapy
timeFrame: From the time of delivery to the time of discharge (about 2-14 days)
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center of Houston
state: Texas
Study officials:
affiliation: University of Texas Health Science Center of Houston
name: Michal Fishel Bartal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 controlled trial. Am J Obstet Gynecol. 2021 Jul;225(1):87.e1-87.e10. doi: 10.1016/j.ajog.2021.04.223. Epub 2021 Apr 15.