DiabetesNCT01950637
GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 6 sites in 6 countries.
Trial summary
This study is conducted Asia, Europe and North America. The aim of this study is to describe insulin therapy adherence and the burden of non-adherence on patient functioning, well-being and diabetes management. 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?
- No treatment given and survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,000 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Jan 2012to Jan 2013
- 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: Insulin treated patients with type 2 diabetes, and HCPs involved in the treatment, management of diabetes and care of patients with type 2 diabetes.
Who may be able to join
- PATIENTS WITH T2DM:
- Diagnosed with type 2 diabetes by a healthcare professional
- Currently being treated with insulin medication, excluding premix insulin treatment
- Age at least 40 years
- Diagnosed as having type 2 diabetes over the age of 40
- HCPs:
Show all 9Show fewer
- Primary care physician, diabetes specialist (diabetologist/endocrinologist) or diabetes specialist nurse/diabetes nurse educator
- Have a minimum of 2 years experience within current speciality
- See a minimum of 20 type 2 diabetes patients per month (40 for diabetes specialists), of which at least 10 per month must be on modern (analogue) inulins
Who cannot join
None listed.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
United States1 site
Novo Nordisk Investigational Site
Princeton, New Jersey, 08540
United Kingdom1 site
Novo Nordisk Investigational Site
Crawley, RH11 9RT
About this study
This study is conducted Asia, Europe and North America. The aim of this study is to describe insulin therapy adherence and the burden of non-adherence on patient functioning, well-being and diabetes management.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- No treatment given, survey
- 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 givenBehavioural
Completion of 90-item online questionnaire.
surveyBehavioural
Completion of 58-item online questionnarie.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes mellitus (T2DM) | Not described Receives: Behavioral: No treatment given | |
| Healthcare professionals (HCPs) | Not described Receives: Behavioral: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal insulin dosing irregularities: frequency of missed doses, mistimed doses, or reduced doses (patient questionnaire)
Measured: In the past 30 days prior to the day when responding to the online questionnaire
Level of patient dosing irregularity: missed, mistimed and reduced dose (HCP questionnaire)
Measured: Day 1 (when responding to the online questionnaire)
Secondary outcomes (3)
Incidence of intentional dosing irregularities and reasons for this behaviour
Measured: Day 1 (when responding to the online questionnaire)
Impact of dosing irregularity on functional well-being
Measured: Day 1 (when responding to the online questionnaire)
Frequency of self-treated hypoglycaemia
Measured: In the past 30 days prior to the day when responding to the online questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 4,000 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
- NCT01950637
- Sponsor's protocol ID
- GAPP2
- Other IDs
- U1111-1136-2536
- Status last verified
- Jan 2017
- First submitted
- 23 Sep 2013
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Brod M, Rana A, Barnett AH. Impact of self-treated hypoglycaemia in type 2 diabetes: a multinational survey in patients and physicians. Curr Med Res Opin. 2012 Dec;28(12):1947-58. doi: 10.1185/03007995.2012.743457. Epub 2012 Nov 14.
PubMed 23150950Brod M, Rana A, Barnett AH. Adherence patterns in patients with type 2 diabetes on basal insulin analogues: missed, mistimed and reduced doses. Curr Med Res Opin. 2012 Dec;28(12):1933-46. doi: 10.1185/03007995.2012.743458. Epub 2012 Nov 14.
PubMed 23150949
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01950637
- Acronym / sponsor ID
- GAPP2
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Sep 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 Asia, Europe and North America. The aim of this study is to describe insulin therapy adherence and the burden of non-adherence on patient functioning, well-being and diabetes management.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes mellitus (T2DM) | – | Behavioral: No treatment given |
| Healthcare professionals (HCPs) | – | Behavioral: survey |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Insulin treated patients with type 2 diabetes, and HCPs involved in the treatment, management of diabetes and care of patients with type 2 diabetes.
Key inclusion criteria (9 listed)
- PATIENTS WITH T2DM:
- Diagnosed with type 2 diabetes by a healthcare professional
- Currently being treated with insulin medication, excluding premix insulin treatment
- Age at least 40 years
- Diagnosed as having type 2 diabetes over the age of 40
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 |
|---|---|---|
| No treatment givenCompletion of 90-item online questionnaire. | Behavioural | Patients with type 2 diabetes mellitus (T2DM) |
| surveyCompletion of 58-item online questionnarie. | Behavioural | Healthcare professionals (HCPs) |
Primary outcome
Basal insulin dosing irregularities: frequency of missed doses, mistimed doses, or reduced doses (patient questionnaire)
Time frame: In the past 30 days prior to the day when responding to the online questionnaire
Level of patient dosing irregularity: missed, mistimed and reduced dose (HCP questionnaire)
Time frame: Day 1 (when responding to the online questionnaire)
3 secondary outcomes
Incidence of intentional dosing irregularities and reasons for this behaviour
Time frame: Day 1 (when responding to the online questionnaire)
Impact of dosing irregularity on functional well-being
Time frame: Day 1 (when responding to the online questionnaire)
Frequency of self-treated hypoglycaemia
Time frame: In the past 30 days prior to the day when responding to the online questionnaire
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 13 Jan 2017.
- Results publication: PubMed 23150950Brod M, Rana A, Barnett AH. Impact of self-treated hypoglycaemia in type 2 diabetes: a multinational survey in patients and physicians. Curr Med Res Opin. 2012 Dec;28(12):1947-58. doi: 10.1185/03007995.2012.743457. Epub 2012 Nov 14.
- Results publication: PubMed 23150949Brod M, Rana A, Barnett AH. Adherence patterns in patients with type 2 diabetes on basal insulin analogues: missed, mistimed and reduced doses. Curr Med Res Opin. 2012 Dec;28(12):1933-46. doi: 10.1185/03007995.2012.743458. Epub 2012 Nov 14.
- 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
6 sites in 6 countries: 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 6 sites in 6 countries.
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 9 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 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada, Denmark, Germany, Japan and 1 more country. 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?
Basal insulin dosing irregularities: frequency of missed doses, mistimed doses, or reduced doses (patient questionnaire) (time frame: In the past 30 days prior to the day when responding to the online questionnaire). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01950637, which also lists 2 linked publications.
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 13 Jan 2017.