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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: September 12, 2014
Last verified: April 2013

April 4, 2013
September 12, 2014
March 2013
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01837680 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes, Gestational
  • Diabetes, Type 2
Drug: Insulin
Other Names:
  • Insulin NPH
  • Insulin Levemir
  • 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.
    Intervention: Drug: Insulin
  • 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.
    Intervention: Drug: Insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
94
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Kimberly M Herrera, MD 212-523-6266 kherrera@chpnet.org
United States
 
NCT01837680
12-166
No
St. Luke's-Roosevelt Hospital Center
St. Luke's-Roosevelt Hospital Center
Not Provided
Not Provided
St. Luke's-Roosevelt Hospital Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP