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

This study has been completed.

First Received: July 17, 2003 Last Updated: October 14, 2009 History of Changes

Sponsor:	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: human insulin Drug: insulin NPH Drug: insulin aspart	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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:

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
Novo Nordisk Clinical Trial Call Center
Santa Barbara, California, United States, 93105

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Campbell Howard, MD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	ANA-2067
Study First Received:	July 17, 2003
Last Updated:	October 14, 2009
ClinicalTrials.gov Identifier:	NCT00065130 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novo Nordisk:

Gestational, Diabetes

Additional relevant MeSH terms:

Hypoglycemic Agents
Pregnancy Complications
Metabolic Diseases
Physiological Effects of Drugs
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Diabetes, Gestational
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 25, 2009