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NCT00593255 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficiency and Safety Profile of Insulin Aspart (NovoRapid®) and Human Soluble Insulin (Novolin® R) as Meal Related Insulin in a Three Times Daily Regimen With One Injection of Novolin® N at Bedtime in Chinese Type 1 and 2 Diabetics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00593255
Other study ID # ANA-1634
Secondary ID
Status Completed
Phase Phase 4
First received January 2, 2008
Last updated December 21, 2016
Start date July 2004
Est. completion date April 2005

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

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date April 2005
Est. primary completion date April 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• soluble human insulin

• insulin aspart

• insulin NPH

Locations
Country Name City State
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Beijing Beijing
China Novo Nordisk Investigational Site Harbin Heilongjiang
China Novo Nordisk Investigational Site Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

References & Publications (1)

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 (200

Outcome
Type Measure Description Time frame Safety issue
Primary 2-hours postprandial plasma glucose (PPPG) after 12 weeks of treatment No
Secondary Percentage of subjects achieving 2-hours PPPG treatment target No
Secondary Percentage of subjects achieving HbA1c treatment target No
Secondary HbA1c No
Secondary Fasting plasma glucose No
Secondary Hypoglycaemic episodes No
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