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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neutral Protamine Hagedorn (NPH) | Active Comparator | NPH will peak between 4-12 hours after injection with a duration of action around 14 hours |
|
| Detemir | Active Comparator | Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neutral Protamine Hagedorn (NPH) | Drug | NPH will peak between 4-12 hours after injection with a duration of action around 14 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Neonates With Composite Adverse Neonatal Outcome | Composite Adverse Neonatal Outcome includes 1 or more of any of the following:
| From the time of delivery to the time of discharge (about 2-14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Mean Fasting Glucose | perinatal to postpartum (32 weeks) | |
| Maternal Mean Post Prandial Glucose | perinatal to postpartum (32 weeks) | |
| Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michal Fishel Bartal, MD | University of Texas Health Science Center of Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center of Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33865836 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Detemir | Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Detemir | Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours) |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Neonates With Composite Adverse Neonatal Outcome | Composite Adverse Neonatal Outcome includes 1 or more of any of the following:
| All participants had singleton pregnancies (that is, there were no twins). | Posted | Count of Participants | Participants | From the time of delivery to the time of discharge (about 2-14 days) |
|
perinatal to postpartum (32 weeks)
All deaths were pregnancy losses, and there were no maternal deaths.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Detemir | Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| First trimester miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michal Fishel Bartal, MD, Assistant Professor | The University of Texas Health Science Center at Houston | 713-500-6421 | Michal.F.Bartal@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2018 | Jul 22, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007336 | Insulin, Isophane |
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Detemir insulin | Drug | Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours) |
|
| perinatal to postpartum (32 weeks) |
| Change in Maternal Weight During Pregnancy | perinatal to postpartum (32 weeks) |
| Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy | Hypertensive disorder includes gestational hypertension, preeclampsia, or superimposed preeclampsia. | perinatal to postpartum (32 weeks) |
| Number of Maternal Subjects Who Had Preeclampsia With Severe Features | perinatal to postpartum (32 weeks) |
| Number of Subjects Who Had Cesarean Delivery | at delivery |
| Number of Subjects Who Had Operative Vaginal Delivery | at delivery |
| Gestational Weeks at Delivery | at delivery |
| 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 |
| Neonatal Hospital Admission Days | From the time of delivery to the time of discharge (about 2-14 days) |
| # 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 |
| Number of Neonates Who Had Jaundice Requiring Therapy | From the time of delivery to the time of discharge (about 2-14 days) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Number of maternal participants who had private insurance for prenatal care | Count of Participants | Participants |
|
| Number of maternal participants who were nulliparous | Nulliparous means never given birth before. | Count of Participants | Participants |
|
| Number of maternal participants with body mass index (BMI) greater than 30 | Count of Participants | Participants |
|
| Number of maternal participants with diabetes mellitus diagnosed before pregnancy | Count of Participants | Participants |
|
| Number of maternal participants with HbA1c level greater than 6.5% | HbA1c level is percentage of red blood cells (RBCs) that have sugar attached to hemoglobin (Hb). | Count of Participants | Participants |
|
| Number of maternal participants with chronic hypertension | Count of Participants | Participants |
|
| Number of maternal participants with depression or anxiety | Count of Participants | Participants |
|
| Number of maternal participants with thyroid disease | Count of Participants | Participants |
|
| Number of maternal participants who smoked during pregnancy | Count of Participants | Participants |
|
| Number of maternal participants who used alcohol during pregnancy | Count of Participants | Participants |
|
| Number of maternal participants who used substances during pregnancy | Count of Participants | Participants |
|
| Number of maternal participants who used rapid- or short-acting insulin | Count of Participants | Participants |
|
| Number of maternal participants who used aspirin during pregnancy | Count of Participants | Participants |
|
| OG000 |
| Detemir |
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours) |
| OG001 | 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 |
|
|
| Secondary | Maternal Mean Fasting Glucose | Data were not collected for this outcome measure. | Posted | perinatal to postpartum (32 weeks) |
|
|
| Secondary | Maternal Mean Post Prandial Glucose | Data were not collected for this outcome measure. | Posted | perinatal to postpartum (32 weeks) |
|
|
| Secondary | Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy | Posted | Count of Participants | Participants | perinatal to postpartum (32 weeks) |
|
|
|
| Secondary | Change in Maternal Weight During Pregnancy | Posted | Median | Inter-Quartile Range | kilograms (kg) | 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. | Posted | Count of Participants | Participants | perinatal to postpartum (32 weeks) |
|
|
|
| Secondary | Number of Maternal Subjects Who Had Preeclampsia With Severe Features | Posted | Count of Participants | Participants | perinatal to postpartum (32 weeks) |
|
|
|
| Secondary | Number of Subjects Who Had Cesarean Delivery | Posted | Count of Participants | Participants | at delivery |
|
|
|
| Secondary | Number of Subjects Who Had Operative Vaginal Delivery | Posted | Count of Participants | Participants | at delivery |
|
|
|
| Secondary | Gestational Weeks at Delivery | Posted | Median | Inter-Quartile Range | weeks | 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. | All participants had singleton pregnancies (that is, there were no twins). | Posted | Count of Participants | Participants | at delivery |
|
|
|
| Secondary | Neonatal Hospital Admission Days | All participants had singleton pregnancies (that is, there were no twins). | Posted | Median | Inter-Quartile Range | 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. | All participants had singleton pregnancies (that is, there were no twins). | Posted | Count of Participants | Participants | 5 minutes after delivery |
|
|
|
| Secondary | Number of Neonates Who Had Jaundice Requiring Therapy | All participants had singleton pregnancies (that is, there were no twins). | Posted | Count of Participants | Participants | From the time of delivery to the time of discharge (about 2-14 days) |
|
|
|
| 4 |
| 57 |
| 16 |
| 57 |
| 0 |
| 53 |
| EG001 | 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 | 1 | 51 | 10 | 51 | 0 | 50 |
| Major fetal anomaly (holoprosencephaly) with termination of pregnancy in 2nd trimester | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Major fetal anomalies (hypoplastic left heart and sacral agenesis) with stillbirth in 2nd trimester | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Maternal admission to the hospital during pregnancy, other than admission for labor | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Maternal readmission to hospital after delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |