Clinical trial NCT01244646: Hypoglycemia- and Weight-related Quality of Life in Patients With Diabetes Mellitus Type 2 on Sulfonylurea Derivatives.
Official title: Perceived Hypoglycemia- and Weight-related Quality of Life of Patients With Sulfonylurea Derivate-treated Diabetes Mellitus Type 2, a Non-interventional Study.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus
Type 2
DMT2
T2DM
metformin
sulfonylurea
hypoglycemia
weight
quality of life
compliance
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 48
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General practitioners, group practices in primary care, pharmacists

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Hypoglycemic Fear Survey (HFS) questionnaire
timeFrame: 0 months
measure: Hypoglycemic Fear Survey (HFS) questionnaire
timeFrame: 3 months
measure: Hypoglycemic Fear Survey (HFS) questionnaire
timeFrame: 6 months
measure: Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire
timeFrame: 0 months
measure: Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire
timeFrame: 3 months
measure: Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Diabetes Symptom Checklist (DSC-R) questionnaire,
timeFrame: 0 months
measure: Diabetes Symptom Checklist (DSC-R) questionnaire,
timeFrame: 3 months
measure: Diabetes Symptom Checklist (DSC-R) questionnaire,
timeFrame: 6 months
measure: Medication Adherence Report Scale (MARS-5) questionnaire
timeFrame: 0 months
measure: Medication Adherence Report Scale (MARS-5) questionnaire
timeFrame: 3 months
measure: Medication Adherence Report Scale (MARS-5) questionnaire
timeFrame: 6 months
measure: Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance
timeFrame: 0 months
measure: Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance
timeFrame: 3 months
measure: Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance
timeFrame: 6 months
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Edam
country: Netherlands
facility: Research Site
city: Gorinchem
country: Netherlands
facility: Research Site
city: Heerhugowaard
country: Netherlands
facility: Research Site
city: Heiloo
country: Netherlands
facility: Research Site
city: Hoogvliet
country: Netherlands
facility: Research Site
city: Lichtenvoorde
country: Netherlands
facility: Research Site
city: Limmen
country: Netherlands
facility: Research Site
city: Maasbracht
country: Netherlands
facility: Research Site
city: Noord-Scharwoude
country: Netherlands
facility: Research Site
city: Poortvliet
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Spijkenisse
country: Netherlands
facility: Research Site
city: Tuitjenhorn
country: Netherlands
facility: Research Site
city: Vaassen
country: Netherlands
facility: Research Site
city: Valkenswaard
country: Netherlands
facility: Research Site
city: Voerendaal
country: Netherlands
facility: Research Site
city: Volendam
country: Netherlands
facility: Research Site
city: Wamel
country: Netherlands
facility: Research Site
city: Zuid-Scharwoude
country: Netherlands
facility: Research Site
city: Zutphen
country: Netherlands
facility: Research Site
Study officials:
affiliation: VU University of Amsterdam
name: Prof. F.J. Snoek, PhD
role: STUDY_CHAIR
References: