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

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

• Registration Number: NCT00593255
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-14
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-21
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
2-hours postprandial plasma glucose (PPPG)	after 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Hypoglycaemic episodes
Percentage of subjects achieving 2-hours PPPG treatment target
Fasting plasma glucose
Percentage of subjects achieving HbA1c treatment target
HbA1c

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Shanghai, Shanghai, China