Diabetes Mellitus Type 2 Clinical Trial
Official title:
Perceived Hypoglycemia- and Weight-related Quality of Life of Patients With Sulfonylurea Derivate-treated Diabetes Mellitus Type 2, a Non-interventional Study.
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. 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.
2. 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.
3. 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.
4. 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.
5. 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.
Status | Terminated |
Enrollment | 48 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | Research Site | Alkmaar | |
Netherlands | Research Site | Den Haag | |
Netherlands | Research Site | Edam | |
Netherlands | Research Site | Gorinchem | |
Netherlands | Research Site | Heerhugowaard | |
Netherlands | Research Site | Heiloo | |
Netherlands | Research Site | Hoogvliet | |
Netherlands | Research Site | Lichtenvoorde | |
Netherlands | Research Site | Limmen | |
Netherlands | Research Site | Maasbracht | |
Netherlands | Research Site | Noord-Scharwoude | |
Netherlands | Research Site | Poortvliet | |
Netherlands | Research Site | Rotterdam | |
Netherlands | Research Site | Spijkenisse | |
Netherlands | Research Site | Tuitjenhorn | |
Netherlands | Research Site | Vaassen | |
Netherlands | Research Site | Valkenswaard | |
Netherlands | Research Site | Voerendaal | |
Netherlands | Research Site | Volendam | |
Netherlands | Research Site | Wamel | |
Netherlands | Research Site | Zuid-Scharwoude | |
Netherlands | Research Site | Zutphen |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hypoglycemic Fear Survey (HFS) questionnaire | 0 months | No | |
Primary | Hypoglycemic Fear Survey (HFS) questionnaire | 3 months | No | |
Primary | Hypoglycemic Fear Survey (HFS) questionnaire | 6 months | No | |
Primary | Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire | 0 months | No | |
Primary | Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire | 3 months | No | |
Primary | Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire | 6 months | No | |
Secondary | Diabetes Symptom Checklist (DSC-R) questionnaire, | 0 months | No | |
Secondary | Diabetes Symptom Checklist (DSC-R) questionnaire, | 3 months | No | |
Secondary | Diabetes Symptom Checklist (DSC-R) questionnaire, | 6 months | No | |
Secondary | Medication Adherence Report Scale (MARS-5) questionnaire | 0 months | No | |
Secondary | Medication Adherence Report Scale (MARS-5) questionnaire | 3 months | No | |
Secondary | Medication Adherence Report Scale (MARS-5) questionnaire | 6 months | No | |
Secondary | Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance | 0 months | No | |
Secondary | Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance | 3 months | No | |
Secondary | Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance | 6 months | No |
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