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

Insulin Detemir Versus Insulin NPH: A Randomized Prospective Study Comparing Glycemic Control in Pregnant Women With Diabetes

The aim of this study is to compare glycemic control in pregnant women treated with insulin Detemir and pregnant women treated with NPH insulin. These women are diagnosed with gestational diabetes (GDM) in the current pregnancy or have a preexisting diagnosis of type 2 diabetes (T2DM) at the onset of pregnancy. Our hypothesis is that there is no difference between these two treatment modalities in terms of glycemic control in diabetes.

Study Overview

• Status: Completed
• Conditions: Diabetes, Gestational; Diabetes, Type 2
• Intervention / Treatment: Drug: Insulin

Detailed Description

The experimental method will be a randomized controlled trial performed at Roosevelt Hospital in our Diabetes in Pregnancy Program (DIPP). Perinatologists managing the patient in DIPP determine when patients need further treatment with medical therapy. Patients undergoing care at DIPP may require medical intervention in the following clinical scenarios: failure of diet alone to control glycemic indices and grossly abnormal glucose tolerance screening test results suggesting disease of such severity that diet alone would not be sufficient. After verbally counseling the patient, she will be recruited for the study by the investigators. An extensive explanation of the objectives of the study will be presented to the patient, as well as written copies of the protocol and consent. After informed consent is given, patients will be randomized to management with either insulin NPH or detemir together with rapid acting insulin aspart (Novolog) with meals, as necessary. The primary outcome will be level of glycemic control defined as overall mean blood glucose in pregnancy. This is a well established measure of overall glycemic control that has been used in numerous publications in the obstetric literature on diabetes in pregnancy. Participants will be followed until they deliver, with an expected range of 6-16 weeks depending on when the patient was enrolled in the study. The mean glucose will be determined by the sum of average glucose at each visit divided by the number of visits).

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • St. Luke's-Roosevelt Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion criteria:

• All pregnant women with a viable singleton or multiple gestation at ≤34 weeks with gestational diabetes diagnosed in their current pregnancy requiring medical therapy. "Early diagnosis" GDM patients will also be included; which is defined as a diagnosis made prior to 24 weeks.
• Women with known preexisting type 2 diabetes that are in need of medical therapy.

Exclusion criteria:

• Patients <18 years of age
• a diagnosis of GDM outside of the gestational age stated above
• known allergy/prior adverse reaction to insulin NPH or insulin detemir.
• type 1 diabetes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Levemir; Initial daily total insulin doses will be determined as per a weight based protocol depending on what trimester the patient is in. Sixty percent of the total daily insulin dose will be allotted to the morning total dose of insulin, while the remaining 40% will be allotted to the evening total dose. Of the morning dose, 2/3 will be allotted to the long acting insulin and 1/3 to short acting insulin. She will take half of the short-acting dose with breakfast and the other half with lunch. The evening insulin dose (40% of the total dose) will be divided in two: half the dose will be taken as short-acting insulin with dinner, and the other half as long acting insulin at bedtime. Doses are rounded down if decimals are present.	Drug: Insulin; Other Names: Insulin Levemir; Insulin NPH
Active Comparator: NPH; Initial daily total insulin doses will be determined as per a weight based protocol depending on what trimester the patient is in. Sixty percent of the total daily insulin dose will be allotted to the morning total dose of insulin, while the remaining 40% will be allotted to the evening total dose. Of the morning dose, 2/3 will be allotted to the long acting insulin and 1/3 to short acting insulin. She will get the entire dose of short-acting insulin with breakfast. The evening insulin dose (40% of the total dose) will be divided in two: half the dose will be taken as short-acting insulin with dinner, and the other half as long acting insulin at bedtime. Doses are rounded down if decimals are present.	Drug: Insulin; Other Names: Insulin Levemir; Insulin NPH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Control	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.	up to 41 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Obtaining Glycemic Control	Number of each group that obtains glycemic control, defined as mean glucose <100mg/dl.	up to 41 weeks
Time to Achieve Glycemic Control	Time (weeks) to achieve glycemic control, as defined as mean glucose <100mg/dl	up to 41 weeks
Average Fasting Glucose	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	up to 41 weeks
Post-prandial Blood Glucose	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.	up to 41 weeks
Weight Gain	Total weight gain in pregnancy	Number of pounds gained at each visit up to 41 weeks
Neonatal Weight	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	At delivery, up to 41 weeks
Gestational Age at Delivery	Gestational age at delivery	at delivery, up to 41 weeks
Maternal Hypoglycemia	Number of participants with incidence of maternal hypoglycemia (<60mg/dl)	at delivery, up to 41 weeks
Neonatal Bilirubin	Percentage of neonatal hyperbilirubinemia - data not collected	at birth, up to 41 weeks
Intensive Care Admissions	Number of participants with incidence of neonatal intensive care unit admissions	at birth, up to 41 weeks
Delivery Mode	method of delivery including cesarean section, vaginal delivery, or assisted vaginal delivery - data not collected	at birth, up to 41 weeks
Birth Rate	Number of live birth rate	at birth, up to 41 weeks
Shoulder Dystocia	Incidence of shoulder dystocia - data not collected	at birth, up to 41 weeks
Polyhydramnios	Incidence of polyhydramnios (defined as amniotic fluid index (AFI)>20 or deepest vertical pocket ≥8) - data not collected	at each visit in pregnancy up to 41 weeks
Neonatal Hypoglycemia	Number of participants with incidence of blood sugar <40mg/dl in neonate	at birth, up to 41 weeks

Collaborators and Investigators

• Sponsor: St. Luke's-Roosevelt Hospital Center

Publications and helpful links

General Publications

• Herrera KM, Rosenn BM, Foroutan J, Bimson BE, Al Ibraheemi Z, Moshier EL, Brustman LE. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol. 2015 Sep;213(3):426.e1-7. doi: 10.1016/j.ajog.2015.06.010. Epub 2015 Jun 9.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: April 22, 2013
• First Posted (Estimate): April 23, 2013

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Insulin, Long-Acting
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes, Gestational; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 12-166