DiabetesNCT01538589
Special Survey for Patients With Type 1 or Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- insulin aspart
- How many people
- 1,582 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2003to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diabetes requiring insulin therapy with no treatment history of insulin aspart (NovoRapid®)
Who may be able to join
- Patients with no treatment history of insulin aspart (NovoRapid®)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Special Survey for Type 1 or Type 2 Diabetic Patients
This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice.
- Being tested
- insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin aspartDrug
Prescribed by the physicians as a result of normal clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Insulin aspart users | Not described Receives: Drug: insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of severe hypoglycaemic symptoms
Measured: Year 1
Occurrence of severe hypoglycaemic symptoms
Measured: Year 2 for patients who had an antibody titre test performed
Antibody titre findings
Measured: Year 1
Antibody titre findings
Measured: Year 2 for patients who had an antibody titre test performed
Adverse events
Measured: Year 1
Adverse events
Measured: Year 2 for patients who had an antibody titre test performed
Secondary outcomes (6)
Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control
Measured: Year 1
Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control
Measured: Year 2 for patients who had an antibody titre test performed
HbA1c (glycosylated haemoglobin)
Measured: Year 1
HbA1c (glycosylated haemoglobin)
Measured: Year 2 for patients who had an antibody titre test performed
Total dose of insulin infused subcutaneously
Measured: Year 1
Total dose of insulin infused subcutaneously
Measured: Year 2 for patients who had an antibody titre test performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startDec 2003
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538589
- Sponsor's protocol ID
- BIASP-1943
- Status last verified
- Mar 2016
- First submitted
- 15 Feb 2012
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Survey for Type 1 or Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01538589
- Acronym / sponsor ID
- BIASP-1943
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,582 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin aspart users | – | Drug: insulin aspart |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diabetes requiring insulin therapy with no treatment history of insulin aspart (NovoRapid®)
Key inclusion criteria (1 listed)
- Patients with no treatment history of insulin aspart (NovoRapid®)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin aspartPrescribed by the physicians as a result of normal clinical practice | Drug | Insulin aspart users |
Primary outcome
Occurrence of severe hypoglycaemic symptoms
Time frame: Year 1
Occurrence of severe hypoglycaemic symptoms
Time frame: Year 2 for patients who had an antibody titre test performed
Antibody titre findings
Time frame: Year 1
Antibody titre findings
Time frame: Year 2 for patients who had an antibody titre test performed
Adverse events
Time frame: Year 1
Adverse events
Time frame: Year 2 for patients who had an antibody titre test performed
6 secondary outcomes
Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control
Time frame: Year 1
Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control
Time frame: Year 2 for patients who had an antibody titre test performed
HbA1c (glycosylated haemoglobin)
Time frame: Year 1
HbA1c (glycosylated haemoglobin)
Time frame: Year 2 for patients who had an antibody titre test performed
Total dose of insulin infused subcutaneously
Time frame: Year 1
Total dose of insulin infused subcutaneously
Time frame: Year 2 for patients who had an antibody titre test performed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of severe hypoglycaemic symptoms (time frame: Year 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.