DiabetesDiabCare AsiaNCT01957592
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Sri Lanka
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S.
Trial summary
This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Sri Lanka. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- No treatment given
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People having been treated for at least a year are eligible for the study. The selection of the patients will be done randomly by the individual physician involved in the study.
Who may be able to join
- People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months
- Patients willing to sign informed consent form
Who cannot join
- Previous participation in this study
- Unable to comply with protocol requirements
- Confirmed or suspected pregnancy
About this study
This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Sri Lanka.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- No treatment given
- 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.
No treatment givenOther
Patients will fill out a questionnaire by interview.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with diabetes mellitus (type 2) | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7%
Measured: Evaluated at the first visit (only one study visit)
Secondary outcomes (9)
Mean Fasting Plasma Glucose (FPG) of patients
Measured: Evaluated at the first visit (only one study visit)
Mean Postprandial Plasma Glucose (PPG) of patients
Measured: Evaluated at the first visit (only one study visit)
Mean HbA1c of patients
Measured: Evaluated at the first visit (only one study visit)
Proportion of patients having dyslipidemia
Measured: Evaluated at the first visit (only one study visit)
Proportion of patients having hypertension
Measured: Evaluated at the first visit (only one study visit)
Proportion of patients having cardiovascular complications
Measured: Evaluated at the first visit (only one study visit)
Proportion of patients having peripheral vascular disease
Measured: Evaluated at the first visit (only one study visit)
Proportion of patients having diabetic nephropathy
Measured: Evaluated at the first visit (only one study visit)
Proportion of patients having diabetic eye complications
Measured: Evaluated at the first visit (only one study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 0 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
- NCT01957592
- Sponsor's protocol ID
- INS-4068
- Other IDs
- U1111-1138-8495
- Acronym
- DiabCare Asia
- Status last verified
- Oct 2014
- First submitted
- 1 Oct 2013
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Sri Lanka
- ClinicalTrials.gov ID
- NCT01957592
- Acronym / sponsor ID
- DiabCare Asia / INS-4068
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 8 Oct 2013 (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 non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Sri Lanka.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with diabetes mellitus (type 2) | – | Other: No treatment given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People having been treated for at least a year are eligible for the study. The selection of the patients will be done randomly by the individual physician involved in the study.
Key inclusion criteria (2 listed)
- People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months
- Patients willing to sign informed consent form
Key exclusion criteria (3 listed)
- Previous participation in this study
- Unable to comply with protocol requirements
- Confirmed or suspected pregnancy
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 |
|---|---|---|
| No treatment givenPatients will fill out a questionnaire by interview. | Other | Subjects with diabetes mellitus (type 2) |
Primary outcome
Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7%
Time frame: Evaluated at the first visit (only one study visit)
9 secondary outcomes
Mean Fasting Plasma Glucose (FPG) of patients
Time frame: Evaluated at the first visit (only one study visit)
Mean Postprandial Plasma Glucose (PPG) of patients
Time frame: Evaluated at the first visit (only one study visit)
Mean HbA1c of patients
Time frame: Evaluated at the first visit (only one study visit)
Proportion of patients having dyslipidemia
Time frame: Evaluated at the first visit (only one study visit)
Proportion of patients having hypertension
Time frame: Evaluated at the first visit (only one study visit)
Proportion of patients having cardiovascular complications
Time frame: Evaluated at the first visit (only one study visit)
Proportion of patients having peripheral vascular disease
Time frame: Evaluated at the first visit (only one study visit)
Proportion of patients having diabetic nephropathy
Time frame: Evaluated at the first visit (only one study visit)
Proportion of patients having diabetic eye complications
Time frame: Evaluated at the first visit (only one study visit)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- 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
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.
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 3 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: withdrawn, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7% (time frame: Evaluated at the first visit (only one study visit)). 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 2 Oct 2014.