DiabetesNCT02230631
A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 1 site in Brazil.
Trial summary
This survey is conducted in South America. The aim of this survey is to investigate hypoglycaemia among Insulin-treated patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- No treatment given
- How many people
- 704 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2014to Mar 2015
- 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: Twenty-five sites will be selected, distributed in different regions of the country, in order to be representative of the Brazilian population.
Who may be able to join
- Informed consent obtained before any study-related activities
- The following patients will be considered eligible for inclusion in the study: Patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) treated with insulin for more than 12 months and patients at least 18 years of age at the time of the survey
Who cannot join
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Illiterate patients and patients otherwise unable to complete a written survey
- Non-ambulatory patients
- Simultaneous participation in any other clinical study with an investigational product
Trial locations and contacts
1 site in 1 country.
About this study
This survey is conducted in South America. The aim of this survey is to investigate hypoglycaemia among Insulin-treated patients with diabetes.
- Being tested
- No treatment given
- 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.
No treatment givenOther
Two different questionnaires will be applied to patients during a regular clinical visit.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (retrospective cross-sectional evaluation) | Not described Receives: Other: No treatment given | |
| Part 2 (prospective observational evaluation) | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients experiencing at least 1 hypoglycaemic event
Measured: During 4 weeks from baseline visit
Secondary outcomes (8)
Hypoglycaemic events requiring hospital admission
Measured: In the 6 months prior to (Part 1 SAQ, Self-Assessment questionnaire) and 4 weeks following (Part 2 SAQ) the baseline visit
Severe hypoglycaemic events
Measured: In the 6 months prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
Non-severe hypoglycaemic events
Measured: In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
Nocturnal hypoglycaemic events
Measured: In the 4 weeks prior to (Part 1 SAQ) and following (Part 2 SAQ) the baseline visit
Documented symptomatic hypoglycaemic events
Measured: In the 4 weeks following the baseline visit (Patient Diary)
Hypoglycaemic events associated with a blood glucose measurement below 56 mg/dL irrespective of symptoms
Measured: In the 4 weeks following the baseline visit (Patient Diary)
All hypoglycaemic events (any type)
Measured: In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
Difference in the reported incidence rates of hypoglycaemia
Measured: In the 4 weeks prior to (Part 1 SAQ) versus 4 weeks following (Part 2 SAQ) the baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
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
- 704 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
- NCT02230631
- Sponsor's protocol ID
- INS-4142
- Other IDs
- U1111-1147-4179
- Status last verified
- Apr 2015
- First submitted
- 29 Aug 2014
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
- ClinicalTrials.gov ID
- NCT02230631
- Acronym / sponsor ID
- INS-4142
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Sep 2014 (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 survey is conducted in South America. The aim of this survey is to investigate hypoglycaemia among Insulin-treated patients with diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 (retrospective cross-sectional evaluation) | – | Other: No treatment given |
| Part 2 (prospective observational evaluation) | – | 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
- Twenty-five sites will be selected, distributed in different regions of the country, in order to be representative of the Brazilian population.
Key inclusion criteria (2 listed)
- Informed consent obtained before any study-related activities
- The following patients will be considered eligible for inclusion in the study: Patients with T1DM (Type 1 Diabetes Mellitus) or T2DM (Type 2 Diabetes Mellitus) treated with insulin for more than 12 months and patients at least 18 years of age at the time of the survey
Key exclusion criteria (4 listed)
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Illiterate patients and patients otherwise unable to complete a written survey
- Non-ambulatory patients
- Simultaneous participation in any other clinical study with an investigational product
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 givenTwo different questionnaires will be applied to patients during a regular clinical visit. | Other | Part 1 (retrospective cross-sectional evaluation), Part 2 (prospective observational evaluation) |
Primary outcome
The percentage of patients experiencing at least 1 hypoglycaemic event
Time frame: During 4 weeks from baseline visit
8 secondary outcomes
Hypoglycaemic events requiring hospital admission
Time frame: In the 6 months prior to (Part 1 SAQ, Self-Assessment questionnaire) and 4 weeks following (Part 2 SAQ) the baseline visit
Severe hypoglycaemic events
Time frame: In the 6 months prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
Non-severe hypoglycaemic events
Time frame: In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
Nocturnal hypoglycaemic events
Time frame: In the 4 weeks prior to (Part 1 SAQ) and following (Part 2 SAQ) the baseline visit
Documented symptomatic hypoglycaemic events
Time frame: In the 4 weeks following the baseline visit (Patient Diary)
Hypoglycaemic events associated with a blood glucose measurement below 56 mg/dL irrespective of symptoms
Time frame: In the 4 weeks following the baseline visit (Patient Diary)
All hypoglycaemic events (any type)
Time frame: In the 4 weeks prior to (Part 1 SAQ) and 4 weeks following (Part 2 SAQ) the baseline visit
Difference in the reported incidence rates of hypoglycaemia
Time frame: In the 4 weeks prior to (Part 1 SAQ) versus 4 weeks following (Part 2 SAQ) the baseline visit
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 9 Apr 2015.
- 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 Brazil.
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 4 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 9 Apr 2015. 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 Brazil. 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?
The percentage of patients experiencing at least 1 hypoglycaemic event (time frame: During 4 weeks from baseline 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 9 Apr 2015.