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

Phase 3

Completed

• Conditions: Gestational Diabetes; Diabetes

• Registration Number: NCT00065130
• Lead Sponsor: Novo Nordisk A/S

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 available

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2003-07-17
• Study First Submitted QC: 2003-07-17
• Study First Posted: 2003-07-18
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postprandial glycemic control

Secondary Outcome Measures

Name	Time	Method
HbA1c (glycosylated haemoglobin A1c)
Hypoglycemic episodes
Adverse events
Postprandial endogenous insulin secretory response

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Santa Barbara, California, United States