Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes
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
1 other identifier
interventional
220
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes
Started Jul 2004
Shorter than P25 for phase_4 diabetes
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 2, 2008
CompletedFirst Posted
Study publicly available on registry
January 14, 2008
CompletedDecember 22, 2016
December 1, 2016
9 months
January 2, 2008
December 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
2-hours postprandial plasma glucose (PPPG)
after 12 weeks of treatment
Secondary Outcomes (5)
Percentage of subjects achieving 2-hours PPPG treatment target
Percentage of subjects achieving HbA1c treatment target
HbA1c
Fasting plasma glucose
Hypoglycaemic episodes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (5)
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100034, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100101, China
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100853, China
Novo Nordisk Investigational Site
Harbin, Heilongjiang, 150001, China
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200433, China
Related 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 (2005-PO)
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2008
First Posted
January 14, 2008
Study Start
July 1, 2004
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
December 22, 2016
Record last verified: 2016-12