DiabetesNCT01950650
GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus
An observational study of Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 10 sites in 10 countries.
Trial summary
This study is conducted in Asia, Europe and in the United States of America. The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens. 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?
- No treatment given and survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,800 participants
- Where
- 10 sitesin 10 countries
- Study dates
- Mar 2010to Sep 2010
- 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 diabetes (type 1 or 2), and physicians involved in the treatment, management of diabetes and care of patients with diabetes.
Who may be able to join
- PATIENTS WITH DIABETES:
- Age 18 years or older
- Treated with insulin
- Type 1 or Type 2 diabetes
- PHYSICIANS:
- In practice for more than 1 year since completing residency
- See a minimum number of patients with diabetes per week (primary care physicians 5, specialists 10)
- Initiate insulin treatment for patients with diabetes
Who cannot join
None listed.
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
United States1 site
Novo Nordisk Investigational Site
Princeton, New Jersey, 08540
China1 site
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100004
Turkey (Türkiye)1 site
Novo Nordisk Investigational Site
Istanbul, 34335
United Kingdom1 site
Novo Nordisk Investigational Site
Crawley, RH11 9RT
About this study
This study is conducted in Asia, Europe and in the United States of America. The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.
- Being tested
- No treatment given, survey
- 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 givenBehavioural
Survey conducted through computer-assisted telephone interviewing.
surveyBehavioural
Survey conducted via the Internet.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes | Not described Receives: Behavioral: No treatment given | |
| Physicians | Not described Receives: Behavioral: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of insulin omission/non-adherence
Measured: In the past 30 days prior to the day when responding to the survey (patient survey)
Reasons for insulin omission/non-adherence reported by patient and physician
Measured: Day 1 (when responding to the survey)
Secondary outcomes (1)
Impact of insulin treatment on life domains (patient survey)
Measured: Day 1 (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 startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 1,800 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
- NCT01950650
- Sponsor's protocol ID
- GAPP1
- Other IDs
- U1111-1136-2507
- Status last verified
- Apr 2017
- First submitted
- 23 Sep 2013
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012 May;29(5):682-9. doi: 10.1111/j.1464-5491.2012.03605.x.
PubMed 22313123
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01950650
- Acronym / sponsor ID
- GAPP1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (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 in Asia, Europe and in the United States of America. The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes | – | Behavioral: No treatment given |
| Physicians | – | Behavioral: survey |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Insulin treated patients with diabetes (type 1 or 2), and physicians involved in the treatment, management of diabetes and care of patients with diabetes.
Key inclusion criteria (8 listed)
- PATIENTS WITH DIABETES:
- Age 18 years or older
- Treated with insulin
- Type 1 or Type 2 diabetes
- PHYSICIANS:
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 givenSurvey conducted through computer-assisted telephone interviewing. | Behavioural | Patients with diabetes |
| surveySurvey conducted via the Internet. | Behavioural | Physicians |
Primary outcome
Frequency of insulin omission/non-adherence
Time frame: In the past 30 days prior to the day when responding to the survey (patient survey)
Reasons for insulin omission/non-adherence reported by patient and physician
Time frame: Day 1 (when responding to the survey)
1 secondary outcome
Impact of insulin treatment on life domains (patient survey)
Time frame: Day 1 (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 27 Apr 2017.
- Results publication: PubMed 22313123Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012 May;29(5):682-9. doi: 10.1111/j.1464-5491.2012.03605.x.
- 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
10 sites in 10 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 1, run by Novo Nordisk A/S at 10 sites in 10 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 8 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 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, China, France, Germany, India and 5 more countries. 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?
Frequency of insulin omission/non-adherence (time frame: In the past 30 days prior to the day when responding to the survey (patient survey)). 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 NCT01950650, which also lists 1 linked publication.
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 27 Apr 2017.