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Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy (Determin)

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ClinicalTrials.gov Identifier: NCT03620890
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Michal Fishel Bartal, 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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Neutral Protamine Hagedorn (NPH) Drug: Detemir insulin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy: a Comparative-effectiveness, Open Label, Randomized Controlled Trial
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Neutral Protamine Hagedorn (NPH)
NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
Drug: Neutral Protamine Hagedorn (NPH)
NPH will peak between 4-12 hours after injection with a duration of action around 14 hours

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




Primary Outcome Measures :
  1. Composite adverse neonatal outcome [ Time Frame: at the time of discharge (about 2-7 days after birth) ]

    Adverse Neonatal Outcome includes 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 :
  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. Maternal # of subjects who experienced Hypoglycemic events (<60 mg/dl) [ Time Frame: perinatal to postpartum (32 weeks) ]
  4. Maternal weight gain during pregnancy [ Time Frame: perinatal to postpartum (32 weeks) ]
  5. # of subjects who had Gestational hypertension [ Time Frame: perinatal to postpartum (32 weeks) ]
  6. # of subjects who had Preeclampsia [ Time Frame: perinatal to postpartum (32 weeks) ]
  7. # of subjects who had Cesarean delivery [ Time Frame: at delivery ]
  8. # of subjects who had Operative vaginal delivery [ Time Frame: at delivery ]
  9. Neonatal Gestational age at delivery [ Time Frame: at delivery ]
  10. # of neonates who where Small for gestational age (SGA) [ Time Frame: at delivery ]
  11. Neonatal intensive care unit (NICU) length of stay [ Time Frame: delivery to discharge (2-7 days) ]
  12. # of neonates who had 5-minute Apgar score ≤ 5 [ Time Frame: 5 min. after delivery ]
  13. # of neonates who had jaundice requiring therapy [ Time Frame: delivery to discharge (2-7 days) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620890


Contacts
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Contact: Michal Fishel Bartal, MD 713-500-6421 Michal.F.Bartal@uth.tmc.edu
Contact: Sunbola Ashimi Ademola, PhD 713-500-6410 sunbola.s.ashimi@uth.tmc.edu

Locations
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United States, Texas
University of Texas Health Science Center of Houston Recruiting
Houston, Texas, United States, 77030
Contact: Michal Bartal Fishel, MD    713-500-6421    Michal.F.Bartal@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Michal Fishel Bartal, MD University of Texas Health Science Center of Houston

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Responsible Party: Michal Fishel Bartal, Assistant Professor of OB GYN, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03620890     History of Changes
Other Study ID Numbers: HSC-MS-18-0575
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michal Fishel Bartal, The University of Texas Health Science Center, Houston:
Pregnancy
Additional relevant MeSH terms:
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Protamines
Pregnancy in Diabetics
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants