We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01837680
First Posted: April 23, 2013
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
Results First Submitted: January 12, 2017  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Insulin NPH   Levemir
STARTED   52   53 
COMPLETED   42   45 
NOT COMPLETED   10   8 
Lost to Follow-up                2                2 
lack of insurance                0                2 
allergic reaction                6                0 
switched to oral hypoglycemic or diet                2                4 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Insulin NPH Insulin neutral protamine Hagedorn
Levemir Insulin detemir (IDet)
Total Total of all reporting groups

Baseline Measures
   Insulin NPH   Levemir   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   45   87 
Age 
[Units: Years]
Mean (Full Range)
 35 
 (31 to 38) 
 35 
 (32 to 38) 
 35 
 (31 to 38) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      42 100.0%      45 100.0%      87 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   11   17   28 
Black   7   5   12 
Hispanic   12   15   27 
Native American/Alaskan   12   6   18 
Biracial/Multiracial   0   0   0 
Other   0   2   2 
T2DM [1] 
[Units: Participants]
Count of Participants
 7   7   14 
[1] Type 2 Diabetes Mellitus
GDM in previous pregnancies 
[Units: Participants]
Count of Participants
 8   9   17 
Multiple gestation 
[Units: Participants]
Count of Participants
 2   3   5 
Polycystic ovary syndrome 
[Units: Participants]
Count of Participants
 5   12   17 
Chronic hypertension 
[Units: Participants]
Count of Participants
 5   6   11 
Renal disease 
[Units: Participants]
Count of Participants
 1   5   6 
Thyroid disease 
[Units: Participants]
Count of Participants
 6   8   14 
Prepregnancy body mass index 
[Units: Kg/m^2]
Median (Inter-Quartile Range)
 28.3 
 (24.9 to 33.8) 
 28.6 
 (24.4 to 31.1) 
 28.4 
 (24.5 to 32.3) 
Prepregnancy body status 
[Units: Participants]
Count of Participants
     
Normal   11   14   25 
Obese   14   12   26 
Overweight   12   16   28 
Morbidly obese   4   3   7 
Gestational age diagnosed 
[Units: Weeks]
Median (Inter-Quartile Range)
 26.1 
 (24.8 to 27.1) 
 26.6 
 (25.4 to 28.2) 
 26.3 
 (25.2 to 27.4) 
Previous management 
[Units: Participants]
Count of Participants
     
Diet   35   39   74 
Diet, Metformin   0   1   1 
Glyburide   3   2   5 
Metformin   3   2   5 
Metformin and glyburide   1   0   1 
Other type of insulin   0   1   1 
Gestational age at entry to DIPP 
[Units: Weeks]
Median (Inter-Quartile Range)
 27.3 
 (23.3 to 28.5) 
 28.1 
 (25.1 to 29.3) 
 27.5 
 (24.1 to 29) 
Gestational age insulin started 
[Units: Weeks]
Median (Inter-Quartile Range)
 29.6 
 (27.5 to 31.4) 
 30.0 
 (25.1 to 31.5) 
 30.0 
 (27.3 to 31.4) 
Time between visits 
[Units: Weeks]
Median (Inter-Quartile Range)
 1.5 
 (1.3 to 2.0) 
 1.5 
 (1.3 to 1.8) 
 1.5 
 (1.3 to 1.9) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Glycemic Control   [ Time Frame: up to 41 weeks ]

2.  Secondary:   Number of Patients Obtaining Glycemic Control   [ Time Frame: up to 41 weeks ]

3.  Secondary:   Time to Achieve Glycemic Control   [ Time Frame: up to 41 weeks ]

4.  Secondary:   Average Fasting Glucose   [ Time Frame: up to 41 weeks ]

5.  Secondary:   Post-prandial Blood Glucose   [ Time Frame: up to 41 weeks ]

6.  Secondary:   Weight Gain   [ Time Frame: Number of pounds gained at each visit up to 41 weeks ]

7.  Secondary:   Neonatal Weight   [ Time Frame: At delivery, up to 41 weeks ]

8.  Secondary:   Gestational Age at Delivery   [ Time Frame: at delivery, up to 41 weeks ]

9.  Secondary:   Maternal Hypoglycemia   [ Time Frame: at delivery, up to 41 weeks ]

10.  Secondary:   Neonatal Bilirubin   [ Time Frame: at birth, up to 41 weeks ]

11.  Secondary:   Intensive Care Admissions   [ Time Frame: at birth, up to 41 weeks ]

12.  Secondary:   Delivery Mode   [ Time Frame: at birth, up to 41 weeks ]

13.  Secondary:   Birth Rate   [ Time Frame: at birth, up to 41 weeks ]

14.  Secondary:   Shoulder Dystocia   [ Time Frame: at birth, up to 41 weeks ]

15.  Secondary:   Polyhydramnios   [ Time Frame: at each visit in pregnancy up to 41 weeks ]

16.  Secondary:   Neonatal Hypoglycemia   [ Time Frame: at birth, up to 41 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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
e-mail: kimmerher@gmail.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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