- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01565733
Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes
October 27, 2016 updated by: Novo Nordisk A/S
Multicenter, Open Label, Non-randomized, Non-interventional Observational Study of Safety of Treatment Initiation With a Biphasic Insulin Aspart (NovoMix® 30) in Hospitalized Patients With Type 2 Diabetes Mellitus
This study is conducted in Europe.
The aim of this study is to evaluate the safety and efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2223
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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Warszawa, Poland, PL-02-274
- Novo Nordisk Investigational Site
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with type 2 diabetes requiring treatment with NovoMix® 30 insulin on admission who before hospitalisation had been treated with oral antidiabetics and/or human insulin
Description
Inclusion Criteria:
- Patients with type 2 diabetes
- Treated with oral anti-diabetics and/or human insulin
Exclusion Criteria:
- Persons previously included in the trial
- Hypersensitive to biphasic insulin aspart or any of the excipients
- Pregnant or lactating women, or those who plan to get pregnant within the next 12 months
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
NovoMix® 30 users
|
Biphasic insulin aspart 30 prescribed solely on the basis of clinical judgement.
Initial dose, frequency of injections and further dosage amendments at the discretion of the treating physician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Frequency of severe hypoglycaemic episodes
|
Secondary Outcome Measures
Outcome Measure |
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Number of severe hypoglycaemic episodes
|
Number of mild hypoglycaemic episodes
|
Postprandial glucose concentration after breakfast, lunch, and dinner
|
Average fasting glucose concentration after waking and before main meals
|
Average plasma glucose level at bedtime and at night
|
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.
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
January 1, 2007
Primary Completion (Actual)
July 1, 2007
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
March 26, 2012
First Submitted That Met QC Criteria
March 26, 2012
First Posted (Estimate)
March 29, 2012
Study Record Updates
Last Update Posted (Estimate)
October 31, 2016
Last Update Submitted That Met QC Criteria
October 27, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIASP-4017
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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