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Safety & Efficacy of Insulin Aspart Vs. Regular Human Insulin in Gestational Diabetes

This study has been completed.

Sponsored by: Novo Nordisk
Information provided by: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00065130
  Purpose

The purpose of this study is to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose after meals in women who develop diabetes during pregnancy.


Condition Intervention Phase
Gestational Diabetes
Drug: Novolog (Insulin Aspart)
Drug: Novolin R
Drug: Novolin N
Phase III

MedlinePlus related topics:   Diabetes   

ChemIDplus related topics:   Insulin    Insulin aspart    Insulin, isophane   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Novo Nordisk:

Estimated Enrollment:   40
Estimated Study Completion Date:   December 2003

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

Criteria

Ages Eligible for Study: At least 18 years old. Subjects older than 35 years old will be considered.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065130

Locations
United States, California
Sansum Medical Research Foundation    
      Santa Barbara, California, United States, 93105

Sponsors and Collaborators
Novo Nordisk

Investigators
Study Director:     Campbell Howard, MD     Novo Nordisk    
  More Information


Study ID Numbers:   ANA-2067
First Received:   July 17, 2003
Last Updated:   December 9, 2005
ClinicalTrials.gov Identifier:   NCT00065130
Health Authority:   United States: Food and Drug Administration

Keywords provided by Novo Nordisk:
Gestational, Diabetes  

Study placed in the following topic categories:
Pregnancy Complications
Metabolic Diseases
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases
Diabetes, Gestational
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin, Isophane
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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