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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by St. Luke's-Roosevelt Hospital Center
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01837680
First received: April 4, 2013
Last updated: March 10, 2014
Last verified: April 2013
  Purpose

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.


Condition Intervention
Diabetes, Gestational
Diabetes, Type 2
Drug: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Insulin Detemir Versus Insulin NPH: A Randomized Prospective Study Comparing Glycemic Control in Pregnant Women With Diabetes

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • glycemic control [ Time Frame: up to 41 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Percentage of patients obtaining glycemic control [ Time Frame: up to 41 weeks ] [ Designated as safety issue: Yes ]
    Proportion of each group that obtains glycemic control, defined as mean glucose <100mg/dl.

  • Time to achieve glycemic control [ Time Frame: up to 41 weeks ] [ Designated as safety issue: No ]
    Time (weeks) to achieve glycemic control, as defined as mean glucose <100mg/dl

  • Average fasting glucose [ Time Frame: up to 41 weeks ] [ Designated as safety issue: No ]
    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

  • Post-prandial blood glucose [ Time Frame: up to 41 weeks ] [ Designated as safety issue: No ]
    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.

  • Weight gain [ Time Frame: Number of pounds gained at each visit up to 41 weeks ] [ Designated as safety issue: No ]
    Total weight gain in pregnancy

  • Neonatal weight [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Percentage of neonatal macrosomia (≥4000g birth weight) and neonatal LGA(large for gestational age)(birth weight >90th percentile for gestational age)

  • Gestational age at delivery [ Time Frame: Weeks at delivery ] [ Designated as safety issue: No ]
    Gestational age at delivery

  • Maternal Hypoglycemia [ Time Frame: up to 41 weeks ] [ Designated as safety issue: Yes ]
    Incidence of maternal hypoglycemia (<60mg/dl)

  • Neonatal bilirubin [ Time Frame: at birth ] [ Designated as safety issue: No ]
    Percentage of neonatal hyperbilirubinemia

  • Intensive care admissions [ Time Frame: at birth ] [ Designated as safety issue: No ]
    Number of neonatal intensive care unit admissions

  • Delivery Mode [ Time Frame: at birth ] [ Designated as safety issue: No ]
    method of delivery including cesarean section, vaginal delivery, or assisted vaginal delivery

  • Birth rate [ Time Frame: at birth ] [ Designated as safety issue: Yes ]
    Percentage of live birth rate

  • Shoulder dystocia [ Time Frame: at birth ] [ Designated as safety issue: Yes ]
    Incidence of shoulder dystocia

  • Polyhydramnios [ Time Frame: at each visit in pregnancy up to 41 weeks ] [ Designated as safety issue: No ]
    Incidence of polyhydramnios (defined as amniotic fluid index (AFI)>20 or deepest vertical pocket ≥8)

  • Neonatal hypoglycemia [ Time Frame: at birth ] [ Designated as safety issue: Yes ]
    Incidence of blood sugar <40mg/dl in neonate


Estimated Enrollment: 94
Study Start Date: March 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 NPH
  • Insulin Levemir
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 NPH
  • Insulin Levemir

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837680

Contacts
Contact: Kimberly M Herrera, MD 212-523-6266 kherrera@chpnet.org

Locations
United States, New York
St. Luke's-Roosevelt Hospital Center Recruiting
New York, New York, United States, 10019
Contact: Kimberly M Herrera, MD    212-523-6266    kherrera@chpnet.org   
Principal Investigator: Kimberly M Herrera, MD         
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01837680     History of Changes
Other Study ID Numbers: 12-166
Study First Received: April 4, 2013
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Insulin, Long-Acting

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Diabetes Mellitus, Type 2
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014