- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593255
Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes
December 21, 2016 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
220
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Novo Nordisk Investigational Site
-
Beijing, Beijing, China, 100034
- Novo Nordisk Investigational Site
-
Beijing, Beijing, China, 100101
- Novo Nordisk Investigational Site
-
-
Heilongjiang
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Harbin, Heilongjiang, China, 150001
- Novo Nordisk Investigational Site
-
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Shanghai
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Shanghai, Shanghai, China, 200433
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
2-hours postprandial plasma glucose (PPPG)
Time Frame: after 12 weeks of treatment
|
after 12 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
---|
HbA1c
|
Hypoglycaemic episodes
|
Fasting plasma glucose
|
Percentage of subjects achieving 2-hours PPPG treatment target
|
Percentage of subjects achieving HbA1c treatment target
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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)
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
April 1, 2005
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
January 2, 2008
First Submitted That Met QC Criteria
January 2, 2008
First Posted (Estimate)
January 14, 2008
Study Record Updates
Last Update Posted (Estimate)
December 22, 2016
Last Update Submitted That Met QC Criteria
December 21, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin, Isophane
- Isophane Insulin, Human
- Isophane insulin, beef
Other Study ID Numbers
- ANA-1634
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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