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

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00065130

First received: July 17, 2003

Last updated: May 21, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 17, 2003

Last Updated Date

May 21, 2012

Start Date ^ICMJE

April 2000

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Postprandial glycemic control [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00065130 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Basal/Bolus Therapy for Patients With Gestational Diabetes

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Gestational Diabetes

Intervention ^ICMJE

Drug: human insulin
Drug: insulin NPH
Drug: insulin aspart

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2003

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00065130

Other Study ID Numbers ^ICMJE

ANA-2067

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Campbell Howard, MD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

May 2012

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

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