Diabetes Mellitus Type 2NCT01244646
Hypoglycemia- and Weight-related Quality of Life in Patients With Diabetes Mellitus Type 2 on Sulfonylurea Derivatives.
An observational study of Diabetes Mellitus Type 2, run by AstraZeneca at 22 sites in Netherlands.
Trial summary
1. A prospective, non-interventional study, 125 patients with Diabetes Mellitus Type2 will be enrolled, who, while on metformin, have a sub-optimal glycemic control and who thus will receive additional treatment with a sulfonylurea (SU) derivative. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- How many people
- 48 participants
- Where
- 22 sitesNetherlands
- Study dates
- Dec 2010to Aug 2012
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General practitioners, group practices in primary care, pharmacists
Who may be able to join
- Diabetes Mellitus Type 2 for > 6 months on treatment with only metformin for >4 weeks
- HbA1c value >7.0 and therefore a sulfonylurea derivative is added
- Able to complete a series of questionnaires
Who cannot join
- Concomitant treatment with an other antidiabetic than metformin and SU derivative
- Contraindications for the use of metformin or SU derivative
- Concomitant diseases which may affect the patient's ability to complete study
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Netherlands22 sites
Research Site
Alkmaar
Research Site
Edam
Research Site
Gorinchem
Research Site
Heerhugowaard
Research Site
Heiloo
Research Site
Hoogvliet
Research Site
Lichtenvoorde
Research Site
Limmen
Research Site
Maasbracht
Research Site
Noord-Scharwoude
Research Site
Poortvliet
Research Site
Rotterdam
Research Site
Spijkenisse
Research Site
The Hague
Research Site
Tuitjenhorn
Research Site
Vaassen
Research Site
Valkenswaard
Research Site
Voerendaal
Research Site
Volendam
Research Site
Wamel
Research Site
Zuid-Scharwoude
Research Site
Zutphen
About this study
Official title: Perceived Hypoglycemia- and Weight-related Quality of Life of Patients With Sulfonylurea Derivate-treated Diabetes Mellitus Type 2, a Non-interventional Study.
- A prospective, non-interventional study, 125 patients with Diabetes Mellitus Type2 will be enrolled, who, while on metformin, have a sub-optimal glycemic control and who thus will receive additional treatment with a sulfonylurea (SU) derivative. At the start and at 3 and 6 months, during regular visits to the patient's General Practitioner, the patients will complete a series of questionnaires (Patient Reported Outcomes, PROs) directed at diabetes in general, at fear for hypoglycemia, at body weight, at treatment compliance and at general wellbeing. These PROs are the worry subscale of the Hypoglycaemic Fear Survey, Impact of Weight on Quality of Life, revised Diabetes Symptom Checklist, Problem Areas In Diabetes, EuroQol EQ-5D and Medication Adherence Report Scale. In total 75 questions. The frequency of hypoglycemic symptoms, incidence of hypoglycemic events and body weight changes will be assessed and the level of adherence to treatment will be investigated.
- Diabetic patients, M/F, aged >35, metformin treated, serum HbA1c ≥7.0% (within last month), informed consent provided, in whom a SU therapy is added. Patients with Type 1 diabetes and with secondary diabetes will be excluded, and patients unable to understand and complete the questionnaires.
- Primary outcome variables are outcomes from HFS-w and IWQOL in relation to the frequency of hypoglycemic symptoms and body weight at 6 months and to weight change from 0 to 6 months. Secondary outcome variables are the other PROs. The frequency of hypoglycemic symptoms, incidence of hypoglycemic events, changes in body weight and level of compliance will be addressed.
- The Intention To Treat analysis will be used, with Last Value Extended Forward from 3 to 6 months in case of withdrawal after 3 months. Changes in outcome variables will be analysed by modelling time and potential dummy variables in a Generalized Estimating Equations analysis.
- Secondary, outcomes in HFS-w and IWQOL are compared with self-reported hypoglycemic symptoms, incidence of hypoglycemic events, body weight and change in body weight from 0 to 6 months. Changes in all PRO's from 0 to 3 and 6 months, potential relationships between (changes in) the different questionnaires, such as with hypoglycemia symptoms, weight (changes) and treatment compliance will be evaluated. A search is done for baseline characteristics which predict outcomes and changes in PRO's, hypoglycemic symptoms, hypoglycemic events and weight changes.
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Diabetes Mellitus, Type 2, DMT2, T2DM, metformin, sulfonylurea, hypoglycemia, weight, quality of life, compliance
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hypoglycemia, Body Weight, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with Diabetes Mellitus Type 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemic Fear Survey (HFS) questionnaire
Measured: 0 months
Hypoglycemic Fear Survey (HFS) questionnaire
Measured: 3 months
Hypoglycemic Fear Survey (HFS) questionnaire
Measured: 6 months
Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire
Measured: 0 months
Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire
Measured: 3 months
Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire
Measured: 6 months
Secondary outcomes (9)
Diabetes Symptom Checklist (DSC-R) questionnaire,
Measured: 0 months
Diabetes Symptom Checklist (DSC-R) questionnaire,
Measured: 3 months
Diabetes Symptom Checklist (DSC-R) questionnaire,
Measured: 6 months
Medication Adherence Report Scale (MARS-5) questionnaire
Measured: 0 months
Medication Adherence Report Scale (MARS-5) questionnaire
Measured: 3 months
Medication Adherence Report Scale (MARS-5) questionnaire
Measured: 6 months
Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance
Measured: 0 months
Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance
Measured: 3 months
Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. F.J. Snoek, PhD, Study chair, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244646
- Sponsor's protocol ID
- NIS-CNL-DUM-2010/1
- Status last verified
- Dec 2012
- First submitted
- 18 Nov 2010
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Hypoglycemia- and Weight-related Quality of Life of Patients With Sulfonylurea Derivate-treated Diabetes Mellitus Type 2, a Non-interventional Study.
- ClinicalTrials.gov ID
- NCT01244646
- Acronym / sponsor ID
- NIS-CNL-DUM-2010/1
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Diabetes Mellitus, Type 2, DMT2, T2DM, metformin, sulfonylurea, hypoglycemia, weight
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Nov 2010 (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.
- A prospective, non-interventional study, 125 patients with Diabetes Mellitus Type2 will be enrolled, who, while on metformin, have a sub-optimal glycemic control and who thus will receive additional treatment with a sulfonylurea (SU) derivative. At the start and at 3 and 6 months, during regular visits to the patient's General Practitioner, the patients will complete a series of questionnaires (Patient Reported Outcomes, PROs) directed at diabetes in general, at fear for hypoglycemia, at body weight, at treatment compliance and at general wellbeing. These PROs are the worry subscale of the Hypoglycaemic Fear Survey, Impact of Weight on Quality of Life, revised Diabetes Symptom Checklist, Problem Areas In Diabetes, EuroQol EQ-5D and Medication Adherence Report Scale. In total 75 questions. The frequency of hypoglycemic symptoms, incidence of hypoglycemic events and body weight changes will be assessed and the level of adherence to treatment will be investigated.
- Diabetic patients, M/F, aged >35, metformin treated, serum HbA1c ≥7.0% (within last month), informed consent provided, in whom a SU therapy is added. Patients with Type 1 diabetes and with secondary diabetes will be excluded, and patients unable to understand and complete the questionnaires.
- Primary outcome variables are outcomes from HFS-w and IWQOL in relation to the frequency of hypoglycemic symptoms and body weight at 6 months and to weight change from 0 to 6 months. Secondary outcome variables are the other PROs. The frequency of hypoglycemic symptoms, incidence of hypoglycemic events, changes in body weight and level of compliance will be addressed.
- The Intention To Treat analysis will be used, with Last Value Extended Forward from 3 to 6 months in case of withdrawal after 3 months. Changes in outcome variables will be analysed by modelling time and potential dummy variables in a Generalized Estimating Equations analysis.
- Secondary, outcomes in HFS-w and IWQOL are compared with self-reported hypoglycemic symptoms, incidence of hypoglycemic events, body weight and change in body weight from 0 to 6 months. Changes in all PRO's from 0 to 3 and 6 months, potential relationships between (changes in) the different questionnaires, such as with hypoglycemia symptoms, weight (changes) and treatment compliance will be evaluated. A search is done for baseline characteristics which predict outcomes and changes in PRO's, hypoglycemic symptoms, hypoglycemic events and weight changes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with Diabetes Mellitus Type 2 |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General practitioners, group practices in primary care, pharmacists
Key inclusion criteria (3 listed)
- Diabetes Mellitus Type 2 for > 6 months on treatment with only metformin for >4 weeks
- HbA1c value >7.0 and therefore a sulfonylurea derivative is added
- Able to complete a series of questionnaires
Key exclusion criteria (3 listed)
- Concomitant treatment with an other antidiabetic than metformin and SU derivative
- Contraindications for the use of metformin or SU derivative
- Concomitant diseases which may affect the patient's ability to complete study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypoglycemic Fear Survey (HFS) questionnaire
Time frame: 0 months
Hypoglycemic Fear Survey (HFS) questionnaire
Time frame: 3 months
Hypoglycemic Fear Survey (HFS) questionnaire
Time frame: 6 months
Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire
Time frame: 0 months
Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire
Time frame: 3 months
Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire
Time frame: 6 months
9 secondary outcomes
Diabetes Symptom Checklist (DSC-R) questionnaire,
Time frame: 0 months
Diabetes Symptom Checklist (DSC-R) questionnaire,
Time frame: 3 months
Diabetes Symptom Checklist (DSC-R) questionnaire,
Time frame: 6 months
Medication Adherence Report Scale (MARS-5) questionnaire
Time frame: 0 months
Medication Adherence Report Scale (MARS-5) questionnaire
Time frame: 3 months
Medication Adherence Report Scale (MARS-5) questionnaire
Time frame: 6 months
Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance
Time frame: 0 months
Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance
Time frame: 3 months
Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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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.
Prof. F.J. Snoek, PhD study chair
VU University of Amsterdam
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2, run by AstraZeneca at 22 sites in Netherlands.
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 3 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: stopped early, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Netherlands. 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 was stopped early. Results are not available in the source record.
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?
Hypoglycemic Fear Survey (HFS) questionnaire (time frame: 0 months). The study lists 6 primary outcomes in all. 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 6 Dec 2012.