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

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. Identifier: NCT00065130
Recruitment Status : Completed
First Posted : July 18, 2003
Last Update Posted : December 22, 2016
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Gestational Diabetes Drug: human insulin Drug: insulin NPH Drug: insulin aspart Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Basal/Bolus Therapy for Patients With Gestational Diabetes
Study Start Date : April 2000
Primary Completion Date : December 2003
Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Postprandial glycemic control

Secondary Outcome Measures :
  1. HbA1c (glycosylated haemoglobin A1c)
  2. Postprandial endogenous insulin secretory response
  3. Hypoglycemic episodes
  4. Adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects older than 35 years old will be considered
  • Gestational diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00065130

United States, California
Novo Nordisk Investigational Site
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S Identifier: NCT00065130     History of Changes
Other Study ID Numbers: ANA-2067
First Posted: July 18, 2003    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Isophane insulin, beef
Insulin Aspart
Insulin, Long-Acting
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs