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

December 21, 2016 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93105
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Postprandial glycemic control

Secondary Outcome Measures

Outcome Measure
Adverse events
HbA1c (glycosylated haemoglobin A1c)
Postprandial endogenous insulin secretory response
Hypoglycemic episodes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

July 17, 2003

First Submitted That Met QC Criteria

July 17, 2003

First Posted (Estimate)

July 18, 2003

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANA-2067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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