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

This study has been completed.

First Received on July 17, 2003. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Insulin Insulin beef Insulin, isophane 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:	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:	October 14, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novo Nordisk:

Gestational, Diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012