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Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00065130
First Posted: July 18, 2003
Last Update Posted: December 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
July 17, 2003
July 18, 2003
December 22, 2016
April 2000
December 2003   (Final data collection date for primary outcome measure)
Postprandial glycemic control
Not Provided
Complete list of historical versions of study NCT00065130 on ClinicalTrials.gov Archive Site
  • HbA1c (glycosylated haemoglobin A1c)
  • Postprandial endogenous insulin secretory response
  • Hypoglycemic episodes
  • Adverse events
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Basal/Bolus Therapy for Patients With Gestational Diabetes
This trial is conducted in the United States of America (USA). 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Gestational Diabetes
  • Drug: human insulin
  • Drug: insulin NPH
  • Drug: insulin aspart
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
December 2003
December 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects older than 35 years old will be considered
  • Gestational diabetes mellitus
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00065130
ANA-2067
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
December 2016

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