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Completed

NCT Number: NCT03620890

Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy

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).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Texas Health Science Center of Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neutral Protamine Hagedorn (NPH)

Drug

NPH will peak between 4-12 hours after injection with a duration of action around 14 hours

Detemir insulin

Drug

Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)

Primary outcomes

  1. Number of Neonates With Composite Adverse Neonatal Outcome

    Time frame: 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 outcomes

  1. Maternal Mean Fasting Glucose

    Time frame: perinatal to postpartum (32 weeks)

  2. Maternal Mean Post Prandial Glucose

    Time frame: perinatal to postpartum (32 weeks)

  3. Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy

    Time frame: perinatal to postpartum (32 weeks)

  4. Change in Maternal Weight During Pregnancy

    Time frame: perinatal to postpartum (32 weeks)

  5. Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy

    Time frame: perinatal to postpartum (32 weeks)

    Hypertensive disorder includes gestational hypertension, preeclampsia, or superimposed preeclampsia.

  6. Number of Maternal Subjects Who Had Preeclampsia With Severe Features

    Time frame: perinatal to postpartum (32 weeks)

  7. Number of Subjects Who Had Cesarean Delivery

    Time frame: at delivery

  8. Number of Subjects Who Had Operative Vaginal Delivery

    Time frame: at delivery

  9. Gestational Weeks at Delivery

    Time frame: at delivery

  10. Number of Neonates Who Where Small for Gestational Age (SGA)

    Time frame: 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.

  11. Neonatal Hospital Admission Days

    Time frame: From the time of delivery to the time of discharge (about 2-14 days)

  12. # of Neonates Who Had 5-minute Apgar Score < 7

    Time frame: 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.

  13. Number of Neonates Who Had Jaundice Requiring Therapy

    Time frame: From the time of delivery to the time of discharge (about 2-14 days)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Acronym: Determin

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 8, 2018
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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