Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes

NCT ID: NCT00593255

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

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-04-30

Brief Summary

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This trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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soluble human insulin

Intervention Type DRUG

insulin aspart

Intervention Type DRUG

insulin NPH

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 1 or 2 diabetes for at least 4 weeks
* Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks
* HbA1c: 7.5-13.5%
* Body Mass Index (BMI): 18-35 kg/m2

Exclusion Criteria

* Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation
* History of drug abuse or alcohol dependence
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

Beijing, Beijing Municipality, China

Site Status

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Site Status

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Site Status

Novo Nordisk Investigational Site

Harbin, Heilongjiang, China

Site Status

Novo Nordisk Investigational Site

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Gao Y, Pan C, Zou D, Xu Z, Liu X, Guo X. Superior prandial glucose control with Insulin Aspart compared to Regular Human Insulin in Basal Bolus Therapy with NPH in Patients with Inadequately Controlled T1DM or T2DM. ADA 2006 2006; 55 (Suppl. 1): A464 (2005-PO)

Reference Type RESULT

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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ANA-1634

Identifier Type: -

Identifier Source: org_study_id