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
  Purpose

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 Intervention Phase
Diabetes
Gestational Diabetes
Drug: human insulin
Drug: insulin NPH
Drug: insulin aspart
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Postprandial glycemic control [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: April 2000
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Subjects older than 35 years old will be considered
  • Gestational diabetes mellitus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Campbell Howard, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00065130     History of Changes
Other Study ID Numbers: ANA-2067
Study First Received: July 17, 2003
Last Updated: May 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin, Isophane
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014