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

NCT01837680 | Completed Results

• 1 other identifier: 12-166
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes, Gestational; Diabetes, Type 2

Keywords

Insulin, Long-Acting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Number of Patients Obtaining Glycemic Control

  up to 41 weeks

• Time to Achieve Glycemic Control

  up to 41 weeks

• Average Fasting Glucose

  up to 41 weeks

• Post-prandial Blood Glucose

  up to 41 weeks

• Weight Gain

  Number of pounds gained at each visit up to 41 weeks

Study Arms (2)

Levemir

ACTIVE COMPARATOR

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

NPH

ACTIVE COMPARATOR

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

Interventions

Insulin DRUG

Also known as: Insulin NPH, Insulin Levemir

Levemir; NPH

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

Related Publications (1)

• 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.

  PMID: 26070699 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Insulin; Insulin, Isophane

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Results Point of Contact

• Title: Dr. Kimberly M. Herrera
• Organization: Roosevelt Hospital, Mount Sinai Health System

kimmerher@gmail.com

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 23, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 30, 2017
• Results First Posted: May 30, 2017

Record last verified: 2017-05

Locations

US (1)