Trial Outcomes & Findings for Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy (NCT NCT03620890)
NCT ID: NCT03620890
Last Updated: 2021-09-16
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
108 participants
Primary outcome timeframe
From the time of delivery to the time of discharge (about 2-14 days)
Results posted on
2021-09-16
Participant Flow
Participant milestones
| Measure |
Detemir
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
51
|
|
Overall Study
First Trimester Miscarriage
|
2
|
1
|
|
Overall Study
Major Fetal Anomalies (Hypoplastic Left Heart and Sacral Agenesis) With 2nd Trimester Stillbirth
|
1
|
0
|
|
Overall Study
Major Fetal Anomaly (Holoprosencephaly) With 2nd Trimester Pregnancy Termination
|
1
|
0
|
|
Overall Study
COMPLETED
|
53
|
50
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
Baseline characteristics by cohort
| Measure |
Detemir
n=57 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=51 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 6.2 • n=93 Participants
|
32.5 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
32.3 years
STANDARD_DEVIATION 6.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
36 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
Number of maternal participants who had private insurance for prenatal care
|
22 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Number of maternal participants who were nulliparous
|
5 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Number of maternal participants with body mass index (BMI) greater than 30
|
51 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Number of maternal participants with diabetes mellitus diagnosed before pregnancy
|
44 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Number of maternal participants with HbA1c level greater than 6.5%
|
37 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
|
Number of maternal participants with chronic hypertension
|
12 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Number of maternal participants with depression or anxiety
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Number of maternal participants with thyroid disease
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Number of maternal participants who smoked during pregnancy
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Number of maternal participants who used alcohol during pregnancy
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Number of maternal participants who used substances during pregnancy
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Number of maternal participants who used rapid- or short-acting insulin
|
38 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Number of maternal participants who used aspirin during pregnancy
|
27 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From the time of delivery to the time of discharge (about 2-14 days)Population: All participants had singleton pregnancies (that is, there were no twins).
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
Outcome measures
| Measure |
Detemir
n=53 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
Number of Neonates With Composite Adverse Neonatal Outcome
|
31 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: perinatal to postpartum (32 weeks)Population: Data were not collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: perinatal to postpartum (32 weeks)Population: Data were not collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: perinatal to postpartum (32 weeks)Outcome measures
| Measure |
Detemir
n=53 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy
|
8 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: perinatal to postpartum (32 weeks)Outcome measures
| Measure |
Detemir
n=53 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
Change in Maternal Weight During Pregnancy
|
7.00 kilograms (kg)
Interval 1.0 to 12.0
|
9.00 kilograms (kg)
Interval 4.0 to 14.7
|
SECONDARY outcome
Timeframe: perinatal to postpartum (32 weeks)Hypertensive disorder includes gestational hypertension, preeclampsia, or superimposed preeclampsia.
Outcome measures
| Measure |
Detemir
n=53 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy
|
22 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: perinatal to postpartum (32 weeks)Outcome measures
| Measure |
Detemir
n=53 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
Number of Maternal Subjects Who Had Preeclampsia With Severe Features
|
12 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: at deliveryOutcome measures
| Measure |
Detemir
n=53 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
Number of Subjects Who Had Cesarean Delivery
|
32 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: at deliveryOutcome measures
| Measure |
Detemir
n=53 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
Number of Subjects Who Had Operative Vaginal Delivery
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at deliveryOutcome measures
| Measure |
Detemir
n=53 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
Gestational Weeks at Delivery
|
37.10 weeks
Interval 36.0 to 37.4
|
37.00 weeks
Interval 34.1 to 37.4
|
SECONDARY outcome
Timeframe: at deliveryPopulation: All participants had singleton pregnancies (that is, there were no twins).
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.
Outcome measures
| Measure |
Detemir
n=53 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
Number of Neonates Who Where Small for Gestational Age (SGA)
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From the time of delivery to the time of discharge (about 2-14 days)Population: All participants had singleton pregnancies (that is, there were no twins).
Outcome measures
| Measure |
Detemir
n=53 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
Neonatal Hospital Admission Days
|
4.0 days
Interval 2.0 to 8.0
|
4.1 days
Interval 2.0 to 14.0
|
SECONDARY outcome
Timeframe: 5 minutes after deliveryPopulation: All participants had singleton pregnancies (that is, there were no twins).
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.
Outcome measures
| Measure |
Detemir
n=53 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
# of Neonates Who Had 5-minute Apgar Score < 7
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the time of delivery to the time of discharge (about 2-14 days)Population: All participants had singleton pregnancies (that is, there were no twins).
Outcome measures
| Measure |
Detemir
n=53 Participants
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 Participants
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
Number of Neonates Who Had Jaundice Requiring Therapy
|
15 Participants
|
11 Participants
|
Adverse Events
Detemir
Serious events: 16 serious events
Other events: 0 other events
Deaths: 4 deaths
Neutral Protamine Hagedorn (NPH)
Serious events: 10 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Detemir
n=53 participants at risk；n=57 participants at risk
Detemir insulin: Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
|
Neutral Protamine Hagedorn (NPH)
n=50 participants at risk；n=51 participants at risk
Neutral Protamine Hagedorn (NPH): NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
First trimester miscarriage
|
3.5%
2/57 • Number of events 2 • perinatal to postpartum (32 weeks)
All deaths were pregnancy losses, and there were no maternal deaths.
|
2.0%
1/51 • Number of events 1 • perinatal to postpartum (32 weeks)
All deaths were pregnancy losses, and there were no maternal deaths.
|
|
Pregnancy, puerperium and perinatal conditions
Major fetal anomaly (holoprosencephaly) with termination of pregnancy in 2nd trimester
|
1.8%
1/57 • perinatal to postpartum (32 weeks)
All deaths were pregnancy losses, and there were no maternal deaths.
|
0.00%
0/51 • perinatal to postpartum (32 weeks)
All deaths were pregnancy losses, and there were no maternal deaths.
|
|
Pregnancy, puerperium and perinatal conditions
Major fetal anomalies (hypoplastic left heart and sacral agenesis) with stillbirth in 2nd trimester
|
1.8%
1/57 • perinatal to postpartum (32 weeks)
All deaths were pregnancy losses, and there were no maternal deaths.
|
0.00%
0/51 • perinatal to postpartum (32 weeks)
All deaths were pregnancy losses, and there were no maternal deaths.
|
|
Pregnancy, puerperium and perinatal conditions
Maternal admission to the hospital during pregnancy, other than admission for labor
|
12.3%
7/57 • Number of events 7 • perinatal to postpartum (32 weeks)
All deaths were pregnancy losses, and there were no maternal deaths.
|
15.7%
8/51 • Number of events 8 • perinatal to postpartum (32 weeks)
All deaths were pregnancy losses, and there were no maternal deaths.
|
|
Pregnancy, puerperium and perinatal conditions
Maternal readmission to hospital after delivery
|
8.8%
5/57 • Number of events 5 • perinatal to postpartum (32 weeks)
All deaths were pregnancy losses, and there were no maternal deaths.
|
2.0%
1/51 • Number of events 1 • perinatal to postpartum (32 weeks)
All deaths were pregnancy losses, and there were no maternal deaths.
|
Other adverse events
Adverse event data not reported
Additional Information
Michal Fishel Bartal, MD, Assistant Professor
The University of Texas Health Science Center at Houston
Phone: 713-500-6421
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place