Trial Outcomes & Findings for Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy (NCT NCT01837680)

Last Updated: 2017-05-30

Results Overview

Overall mean glucose value of pregnancy. This will be determined by the sum of average glucose value at each visit, divided by the number of visits.

Recruitment status

COMPLETED

Study phase

Target enrollment

105 participants

Primary outcome timeframe

up to 41 weeks

Results posted on

2017-05-30

Participant Flow

Women with gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) who entered the Diabetes in Pregnancy Program were recruited from March 2013 through October 2014

Participant milestones

Participant milestones
Measure	Insulin NPH Insulin neutral protamine Hagedorn (NPH) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose.	Levemir Insulin detemir (IDet) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose.
Overall Study STARTED	52	53
Overall Study COMPLETED	42	45
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Insulin NPH Insulin neutral protamine Hagedorn (NPH) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose.	Levemir Insulin detemir (IDet) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose.
Overall Study Lost to Follow-up	2	2
Overall Study lack of insurance	0	2
Overall Study allergic reaction	6	0
Overall Study switched to oral hypoglycemic or diet	2	4

Baseline Characteristics

Glycemic Control Using Insulin Levemir Versus Insulin NPH for Diabetes in Pregnancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin NPH n=42 Participants Insulin neutral protamine Hagedorn	Levemir n=45 Participants Insulin detemir (IDet)	Total n=87 Participants Total of all reporting groups
Age, Continuous	35 years n=5 Participants	35 years n=7 Participants	35 years n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	45 Participants n=7 Participants	87 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Black	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Native American/Alaskan	12 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Biracial/Multiracial	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
T2DM	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
GDM in previous pregnancies	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Multiple gestation	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Polycystic ovary syndrome	5 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants
Chronic hypertension	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Renal disease	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Thyroid disease	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Prepregnancy body mass index	28.3 kg/m^2 n=5 Participants	28.6 kg/m^2 n=7 Participants	28.4 kg/m^2 n=5 Participants
Prepregnancy body status Normal	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Prepregnancy body status Obese	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Prepregnancy body status Overweight	12 Participants n=5 Participants	16 Participants n=7 Participants	28 Participants n=5 Participants
Prepregnancy body status Morbidly obese	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Gestational age diagnosed	26.1 weeks n=5 Participants	26.6 weeks n=7 Participants	26.3 weeks n=5 Participants
Previous management Diet	35 Participants n=5 Participants	39 Participants n=7 Participants	74 Participants n=5 Participants
Previous management Diet, Metformin	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Previous management Glyburide	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Previous management Metformin	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Previous management Metformin and glyburide	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Previous management Other type of insulin	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Gestational age at entry to DIPP	27.3 weeks n=5 Participants	28.1 weeks n=7 Participants	27.5 weeks n=5 Participants
Gestational age insulin started	29.6 weeks n=5 Participants	30.0 weeks n=7 Participants	30.0 weeks n=5 Participants
Time between visits	1.5 weeks n=5 Participants	1.5 weeks n=7 Participants	1.5 weeks n=5 Participants

PRIMARY outcome

Timeframe: up to 41 weeks

Overall mean glucose value of pregnancy. This will be determined by the sum of average glucose value at each visit, divided by the number of visits.

Outcome measures

Outcome measures
Measure	Insulin NPH n=42 Participants Insulin neutral protamine Hagedorn	Levemir n=45 Participants Insulin detemir (IDet)
Glycemic Control	109.5 mg/dL Standard Deviation 10.0	107.4 mg/dL Standard Deviation 7.1

SECONDARY outcome

Timeframe: up to 41 weeks

Number of each group that obtains glycemic control, defined as mean glucose \<100mg/dl.

Outcome measures

Outcome measures
Measure	Insulin NPH n=42 Participants Insulin neutral protamine Hagedorn	Levemir n=45 Participants Insulin detemir (IDet)
Number of Patients Obtaining Glycemic Control	28 Participants	35 Participants

SECONDARY outcome

Timeframe: up to 41 weeks

Time (weeks) to achieve glycemic control, as defined as mean glucose \<100mg/dl

Outcome measures

Outcome measures
Measure	Insulin NPH n=42 Participants Insulin neutral protamine Hagedorn	Levemir n=45 Participants Insulin detemir (IDet)
Time to Achieve Glycemic Control	5 weeks Interval 3.0 to 9.0	5 weeks Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: up to 41 weeks

Mean fasting blood glucose in pregnancy, as determined by the sum of the mean fasting glucose at each visit divided by the number of visits

Outcome measures

Outcome measures
Measure	Insulin NPH n=42 Participants Insulin neutral protamine Hagedorn	Levemir n=45 Participants Insulin detemir (IDet)
Average Fasting Glucose	100.7 mg/dL Standard Deviation 10.1	97.3 mg/dL Standard Deviation 7.4

SECONDARY outcome

Timeframe: up to 41 weeks

Mean post-prandial blood glucose in pregnancy, as defined as the sum of the average post-prandial blood glucose at each visit divided by the number of visits.

Outcome measures

Outcome measures
Measure	Insulin NPH n=42 Participants Insulin neutral protamine Hagedorn	Levemir n=45 Participants Insulin detemir (IDet)
Post-prandial Blood Glucose	115.2 mg/dL Standard Deviation 10.2	112.9 mg/dL Standard Deviation 8.9

SECONDARY outcome

Timeframe: Number of pounds gained at each visit up to 41 weeks

Total weight gain in pregnancy

Outcome measures

Outcome measures
Measure	Insulin NPH n=42 Participants Insulin neutral protamine Hagedorn	Levemir n=45 Participants Insulin detemir (IDet)
Weight Gain	27.7 lbs Standard Deviation 15.3	28.6 lbs Standard Deviation 11.6

SECONDARY outcome

Timeframe: At delivery, up to 41 weeks

Neonatal weight was estimated for occurrence of neonatal macrosomia (≥4000g birth weight) and neonatal LGA(large for gestational age)(birth weight \>90th percentile for gestational age

Outcome measures

Outcome measures
Measure	Insulin NPH n=42 Participants Insulin neutral protamine Hagedorn	Levemir n=45 Participants Insulin detemir (IDet)
Neonatal Weight	3230 g Interval 2860.0 to 3530.0	3235 g Interval 2670.0 to 3620.0

SECONDARY outcome

Timeframe: at delivery, up to 41 weeks

Gestational age at delivery

Outcome measures

Outcome measures
Measure	Insulin NPH n=42 Participants Insulin neutral protamine Hagedorn	Levemir n=45 Participants Insulin detemir (IDet)
Gestational Age at Delivery	38.9 weeks Interval 37.6 to 39.3	38.8 weeks Interval 38.1 to 39.1

SECONDARY outcome

Timeframe: at delivery, up to 41 weeks

Number of participants with incidence of maternal hypoglycemia (\<60mg/dl)

Outcome measures

Outcome measures
Measure	Insulin NPH n=42 Participants Insulin neutral protamine Hagedorn	Levemir n=45 Participants Insulin detemir (IDet)
Maternal Hypoglycemia	11 Participants	16 Participants

Adverse Events

Insulin NPH

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Levemir

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Insulin NPH n=52 participants at risk Insulin neutral protamine Hagedorn	Levemir n=53 participants at risk Insulin detemir (IDet)
Skin and subcutaneous tissue disorders Rash	11.5% 6/52 • Number of events 6	0.00% 0/53
Metabolism and nutrition disorders Symptomatic hypoglycemia	21.2% 11/52 • Number of events 28	30.2% 16/53 • Number of events 102
Metabolism and nutrition disorders biochemical event of hypoglycemia	26.9% 14/52 • Number of events 26	50.9% 27/53 • Number of events 136
Metabolism and nutrition disorders Symptomatic nocturnal event	3.8% 2/52	15.1% 8/53

Additional Information

Dr. Kimberly M. Herrera

Roosevelt Hospital, Mount Sinai Health System

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place