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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00065130

Enrollment

Registered

2003-07-18

Start date

2000-04-30

Completion date

2003-12-31

Last updated

2016-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gestational Diabetes

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.

Interventions

DRUGhuman insulin

DRUGinsulin NPH

DRUGinsulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Postprandial glycemic control	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026