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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065130
• Other study ID #: ANA-2067
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2003
• Last updated: December 21, 2016
• Start date: April 2000
• Est. completion date: December 2003

Study information

• Verified date: December 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects older than 35 years old will be considered

• Gestational diabetes mellitus

Study Design

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Drug:
• human insulin

• insulin NPH

• insulin aspart

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (2)

Pettitt DJ, Ospina P, Howard C, Zisser H, Jovanovic L. Efficacy, safety and lack of immunogenicity of insulin aspart compared with regular human insulin for women with gestational diabetes mellitus. Diabet Med. 2007 Oct;24(10):1129-35. — View Citation

Pettitt DJ, Ospina P, Kolaczynski JW, Jovanovic L. Comparison of an insulin analog, insulin aspart, and regular human insulin with no insulin in gestational diabetes mellitus. Diabetes Care. 2003 Jan;26(1):183-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycemic control			No
Secondary	HbA1c (glycosylated haemoglobin A1c)			No
Secondary	Postprandial endogenous insulin secretory response			No
Secondary	Hypoglycemic episodes			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk