Back to resultsSafety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes
Primary Purpose
Diabetes, Gestational Diabetes
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
human insulin
insulin NPH
insulin aspart
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria: Subjects older than 35 years old will be considered Gestational diabetes mellitus
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Postprandial glycemic control
Secondary Outcome Measures
HbA1c (glycosylated haemoglobin A1c)
Postprandial endogenous insulin secretory response
Hypoglycemic episodes
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00065130
Brief Title
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes
Official Title
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Basal/Bolus Therapy for Patients With Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
human insulin
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Primary Outcome Measure Information:
Title
Postprandial glycemic control
Secondary Outcome Measure Information:
Title
HbA1c (glycosylated haemoglobin A1c)
Title
Postprandial endogenous insulin secretory response
Title
Hypoglycemic episodes
Title
Adverse events
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects older than 35 years old will be considered
Gestational diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12502678
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. doi: 10.2337/diacare.26.1.183.
Results Reference
result
PubMed Identifier
17888133
Citation
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. doi: 10.1111/j.1464-5491.2007.02247.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes
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