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

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ClinicalTrials.gov Identifier: NCT01837680
Recruitment Status : Completed
First Posted : April 23, 2013
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes, Gestational
Diabetes, Type 2
Intervention Drug: Insulin
Enrollment 105
Recruitment Details 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
Pre-assignment Details  
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 52 53
Completed 42 45
Not Completed 10 8
Reason Not Completed
Lost to Follow-up             2             2
lack of insurance             0             2
allergic reaction             6             0
switched to oral hypoglycemic or diet             2             4
Arm/Group Title Insulin NPH Levemir Total
Hide Arm/Group Description Insulin neutral protamine Hagedorn Insulin detemir (IDet) Total of all reporting groups
Overall Number of Baseline Participants 42 45 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants 45 participants 87 participants
35
(31 to 38)
35
(32 to 38)
35
(31 to 38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
Female
42
 100.0%
45
 100.0%
87
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
White
11
  26.2%
17
  37.8%
28
  32.2%
Black
7
  16.7%
5
  11.1%
12
  13.8%
Hispanic
12
  28.6%
15
  33.3%
27
  31.0%
Native American/Alaskan
12
  28.6%
6
  13.3%
18
  20.7%
Biracial/Multiracial
0
   0.0%
0
   0.0%
0
   0.0%
Other
0
   0.0%
2
   4.4%
2
   2.3%
T2DM   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
7
  16.7%
7
  15.6%
14
  16.1%
[1]
Measure Description: Type 2 Diabetes Mellitus
GDM in previous pregnancies  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
8
  19.0%
9
  20.0%
17
  19.5%
Multiple gestation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
2
   4.8%
3
   6.7%
5
   5.7%
Polycystic ovary syndrome  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
5
  11.9%
12
  26.7%
17
  19.5%
Chronic hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
5
  11.9%
6
  13.3%
11
  12.6%
Renal disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
1
   2.4%
5
  11.1%
6
   6.9%
Thyroid disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
6
  14.3%
8
  17.8%
14
  16.1%
Prepregnancy body mass index  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 42 participants 45 participants 87 participants
28.3
(24.9 to 33.8)
28.6
(24.4 to 31.1)
28.4
(24.5 to 32.3)
Prepregnancy body status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
Normal
11
  26.2%
14
  31.1%
25
  28.7%
Obese
14
  33.3%
12
  26.7%
26
  29.9%
Overweight
12
  28.6%
16
  35.6%
28
  32.2%
Morbidly obese
4
   9.5%
3
   6.7%
7
   8.0%
Gestational age diagnosed  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 42 participants 45 participants 87 participants
26.1
(24.8 to 27.1)
26.6
(25.4 to 28.2)
26.3
(25.2 to 27.4)
Previous management  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
Diet
35
  83.3%
39
  86.7%
74
  85.1%
Diet, Metformin
0
   0.0%
1
   2.2%
1
   1.1%
Glyburide
3
   7.1%
2
   4.4%
5
   5.7%
Metformin
3
   7.1%
2
   4.4%
5
   5.7%
Metformin and glyburide
1
   2.4%
0
   0.0%
1
   1.1%
Other type of insulin
0
   0.0%
1
   2.2%
1
   1.1%
Gestational age at entry to DIPP  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 42 participants 45 participants 87 participants
27.3
(23.3 to 28.5)
28.1
(25.1 to 29.3)
27.5
(24.1 to 29)
Gestational age insulin started  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 42 participants 45 participants 87 participants
29.6
(27.5 to 31.4)
30.0
(25.1 to 31.5)
30.0
(27.3 to 31.4)
Time between visits  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 42 participants 45 participants 87 participants
1.5
(1.3 to 2.0)
1.5
(1.3 to 1.8)
1.5
(1.3 to 1.9)
1.Primary Outcome
Title Glycemic Control
Hide Description 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.
Time Frame up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 42 45
Mean (Standard Deviation)
Unit of Measure: mg/dL
109.5  (10.0) 107.4  (7.1)
2.Secondary Outcome
Title Number of Patients Obtaining Glycemic Control
Hide Description Number of each group that obtains glycemic control, defined as mean glucose <100mg/dl.
Time Frame up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 42 45
Measure Type: Count of Participants
Unit of Measure: Participants
28
  66.7%
35
  77.8%
3.Secondary Outcome
Title Time to Achieve Glycemic Control
Hide Description Time (weeks) to achieve glycemic control, as defined as mean glucose <100mg/dl
Time Frame up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 42 45
Median (Full Range)
Unit of Measure: weeks
5
(3 to 9)
5
(4 to 7)
4.Secondary Outcome
Title Average Fasting Glucose
Hide Description 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
Time Frame up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 42 45
Mean (Standard Deviation)
Unit of Measure: mg/dL
100.7  (10.1) 97.3  (7.4)
5.Secondary Outcome
Title Post-prandial Blood Glucose
Hide Description 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.
Time Frame up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 42 45
Mean (Standard Deviation)
Unit of Measure: mg/dL
115.2  (10.2) 112.9  (8.9)
6.Secondary Outcome
Title Weight Gain
Hide Description Total weight gain in pregnancy
Time Frame Number of pounds gained at each visit up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 42 45
Mean (Standard Deviation)
Unit of Measure: lbs
27.7  (15.3) 28.6  (11.6)
7.Secondary Outcome
Title Neonatal Weight
Hide Description 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
Time Frame At delivery, up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: g
3230
(2860 to 3530)
3235
(2670 to 3620)
8.Secondary Outcome
Title Gestational Age at Delivery
Hide Description Gestational age at delivery
Time Frame at delivery, up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 42 45
Median (Inter-Quartile Range)
Unit of Measure: weeks
38.9
(37.6 to 39.3)
38.8
(38.1 to 39.1)
9.Secondary Outcome
Title Maternal Hypoglycemia
Hide Description Number of participants with incidence of maternal hypoglycemia (<60mg/dl)
Time Frame at delivery, up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 42 45
Measure Type: Count of Participants
Unit of Measure: Participants
11
  26.2%
16
  35.6%
10.Secondary Outcome
Title Neonatal Bilirubin
Hide Description Percentage of neonatal hyperbilirubinemia - data not collected
Time Frame at birth, up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Intensive Care Admissions
Hide Description Number of participants with incidence of neonatal intensive care unit admissions
Time Frame at birth, up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 42 45
Measure Type: Count of Participants
Unit of Measure: Participants
3
   7.1%
6
  13.3%
12.Secondary Outcome
Title Delivery Mode
Hide Description method of delivery including cesarean section, vaginal delivery, or assisted vaginal delivery - data not collected
Time Frame at birth, up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Birth Rate
Hide Description Number of live birth rate
Time Frame at birth, up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 42 45
Measure Type: Count of Participants
Unit of Measure: Participants
42
 100.0%
45
 100.0%
14.Secondary Outcome
Title Shoulder Dystocia
Hide Description Incidence of shoulder dystocia - data not collected
Time Frame at birth, up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Polyhydramnios
Hide Description Incidence of polyhydramnios (defined as amniotic fluid index (AFI)>20 or deepest vertical pocket ≥8) - data not collected
Time Frame at each visit in pregnancy up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Neonatal Hypoglycemia
Hide Description Number of participants with incidence of blood sugar <40mg/dl in neonate
Time Frame at birth, up to 41 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description:
Insulin neutral protamine Hagedorn
Insulin detemir (IDet)
Overall Number of Participants Analyzed 42 45
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
   4.4%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Insulin NPH Levemir
Hide Arm/Group Description Insulin neutral protamine Hagedorn Insulin detemir (IDet)
All-Cause Mortality
Insulin NPH Levemir
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)      0/53 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Insulin NPH Levemir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/52 (0.00%)      0/53 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Insulin NPH Levemir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/52 (51.92%)      45/53 (84.91%)    
Metabolism and nutrition disorders     
Symptomatic hypoglycemia  11/52 (21.15%)  28 16/53 (30.19%)  102
biochemical event of hypoglycemia [1]  14/52 (26.92%)  26 27/53 (50.94%)  136
Symptomatic nocturnal event  2/52 (3.85%)  8/53 (15.09%) 
Skin and subcutaneous tissue disorders     
Rash  6/52 (11.54%)  6 0/53 (0.00%)  0
[1]
glucose <60mg/dL regardless of presence or absence of symptoms
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Kimberly M. Herrera
Organization: Roosevelt Hospital, Mount Sinai Health System
Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01837680     History of Changes
Other Study ID Numbers: 12-166
First Submitted: April 4, 2013
First Posted: April 23, 2013
Results First Submitted: January 12, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017