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

NCT ID: NCT00065130

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2003-12-31

Brief Summary

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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

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Conditions

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Diabetes Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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human insulin

Intervention Type DRUG

insulin NPH

Intervention Type DRUG

insulin aspart

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects older than 35 years old will be considered
* Gestational diabetes mellitus
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Santa Barbara, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 12502678 (View on PubMed)

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.

Reference Type RESULT
PMID: 17888133 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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ANA-2067

Identifier Type: -

Identifier Source: org_study_id