- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01649570
Safety and Efficacy of Insulin Aspart in Type 2 Diabetes
July 24, 2012 updated by: Novo Nordisk A/S
An Open-labelled, Single-arm, Multi-centre, 6-month Study to Investigate the Safety and Efficacy of NovoRapid as Meal Time Insulin in Type 2 Diabetes Patients Treated on a Basal-bolus Regimen With NPH Human Insulin
This trial is conducted in Japan.
The aim of this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
123
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
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Tokyo, Japan, 103
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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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 diabetes
- Treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks
- HbA1c below or equal to 11.0%
- BMI (body mass index) below 30 kg/m^2
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Insulin aspart
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Administrated subcutaneously (s.c., under the skin) three times a day before each meal for 24 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Incidence of hypoglycaemia
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Secondary Outcome Measures
Outcome Measure |
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Insulin antibodies
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Incidence of adverse events (AEs)
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Clinical laboratory tests: Haematology and biochemistry
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Glycaemic control parameters: Glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPPG)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Henning Andersen, Novo Nordisk A/S
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.
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
March 1, 2002
Primary Completion (Actual)
August 1, 2003
Study Completion (Actual)
August 1, 2003
Study Registration Dates
First Submitted
November 25, 2011
First Submitted That Met QC Criteria
July 24, 2012
First Posted (Estimate)
July 25, 2012
Study Record Updates
Last Update Posted (Estimate)
July 25, 2012
Last Update Submitted That Met QC Criteria
July 24, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANA-1472
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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