DiabetesNCT00806936
Observational Study to Investigate the Efficacy and Safety of Human Insulin or Insulin Analogue Treatments in Type 2 Diabetes Subjects
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in China.
Trial summary
This study is conducted in Asia. The aim of this observational study is to investigate the percentage of patients reaching the treatment target on blood glucose control after treatment with either human insulin or insulin analogues in type 2 diabetes subjects inadequately controlled with two or more oral antidiabetic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- human insulin and insulin analogue
- How many people
- 4,847 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Dec 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: Type 2 diabetic subjects inadequately controlled with two or more oral antidiabetic drugs (OAD) and currently treated with either human insulin or insulin analogues at the discretion of physicians
Who may be able to join
- After the investigator has taken the decision to use human insulin or insulin analogues to treat the subject, any type 2 diabetic previously inadequately controlled with two or more OADs is eligible for the study
- The selection of the subjects will be at the discretion of the individual investigator
Who cannot join
- Known or suspected allergy to trial product(s) or related products
- Subjects who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
- Subjects who previously enrolled in this study
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- The receipt of any investigational product within 3 months prior to this trial
Trial locations and contacts
1 site in 1 country.
China1 site
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100004
About this study
Official title: A 16-week Multicentre, Open Label, Non-interventional, Observational Study to Investigate the Status of Human Insulin or Insulin Analogue Treatments With Focusing on Efficacy and Safety in Type 2 Diabetes Subjects Inadequately Controlled With Two or More Oral Antidiabetic Drugs in China
This study is conducted in Asia. The aim of this observational study is to investigate the percentage of patients reaching the treatment target on blood glucose control after treatment with either human insulin or insulin analogues in type 2 diabetes subjects inadequately controlled with two or more oral antidiabetic drugs in China. Further the safety profiles will be evaluated.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- human insulin, insulin analogue
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human insulinDrug
Any kind of human insulin administered at the discretion of the physician
insulin analogueDrug
Any kind of insulin analogue administered at the discretion of the physician
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: human insulin | |
| B | Not described Receives: Drug: insulin analogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving HbA1c below 7.0%
Measured: at 16 weeks
Secondary outcomes (3)
HbA1c change from baseline
Measured: at 16 weeks
Incidence of major, minor and symptoms only hypoglycaemic episodes
Measured: at 16 weeks
Comparison of scores of Insulin Treatment Appraisal Scale (ITAS)
Measured: at baseline and at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,847 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
- NCT00806936
- Sponsor's protocol ID
- INS-3675
- Status last verified
- Oct 2016
- First submitted
- 10 Dec 2008
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-week Multicentre, Open Label, Non-interventional, Observational Study to Investigate the Status of Human Insulin or Insulin Analogue Treatments With Focusing on Efficacy and Safety in Type 2 Diabetes Subjects Inadequately Controlled With Two or More Oral Antidiabetic Drugs in China
- ClinicalTrials.gov ID
- NCT00806936
- Acronym / sponsor ID
- INS-3675
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,847 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Dec 2008 (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 Asia. The aim of this observational study is to investigate the percentage of patients reaching the treatment target on blood glucose control after treatment with either human insulin or insulin analogues in type 2 diabetes subjects inadequately controlled with two or more oral antidiabetic drugs in China. Further the safety profiles will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: human insulin |
| B | – | Drug: insulin analogue |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 2 diabetic subjects inadequately controlled with two or more oral antidiabetic drugs (OAD) and currently treated with either human insulin or insulin analogues at the discretion of physicians
Key inclusion criteria (2 listed)
- After the investigator has taken the decision to use human insulin or insulin analogues to treat the subject, any type 2 diabetic previously inadequately controlled with two or more OADs is eligible for the study
- The selection of the subjects will be at the discretion of the individual investigator
Key exclusion criteria (5 listed)
- Known or suspected allergy to trial product(s) or related products
- Subjects who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit
- Subjects who previously enrolled in this study
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- The receipt of any investigational product within 3 months prior to this trial
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 |
|---|---|---|
| human insulinAny kind of human insulin administered at the discretion of the physician | Drug | A |
| insulin analogueAny kind of insulin analogue administered at the discretion of the physician | Drug | B |
Primary outcome
Percentage of patients achieving HbA1c below 7.0%
Time frame: at 16 weeks
3 secondary outcomes
HbA1c change from baseline
Time frame: at 16 weeks
Incidence of major, minor and symptoms only hypoglycaemic episodes
Time frame: at 16 weeks
Comparison of scores of Insulin Treatment Appraisal Scale (ITAS)
Time frame: at baseline and at 16 weeks
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 28 Oct 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 2, run by Novo Nordisk A/S at 1 site in China.
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 2 inclusion and 5 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 28 Oct 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 China. 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?
Percentage of patients achieving HbA1c below 7.0% (time frame: at 16 weeks). 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 28 Oct 2016.