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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00065130
First received: July 17, 2003
Last updated: May 21, 2012
Last verified: May 2012

July 17, 2003
May 21, 2012
April 2000
December 2003   (final data collection date for primary outcome measure)
Postprandial glycemic control [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00065130 on ClinicalTrials.gov Archive Site
  • HbA1c (glycosylated haemoglobin A1c) [ Designated as safety issue: No ]
  • Postprandial endogenous insulin secretory response [ Designated as safety issue: No ]
  • Hypoglycemic episodes [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Gestational Diabetes
  • Drug: human insulin
  • Drug: insulin NPH
  • Drug: insulin aspart
Not Provided
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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065130
ANA-2067
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Campbell Howard, MD Novo Nordisk A/S
Novo Nordisk A/S
May 2012

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