Hypoglycemia- and Weight-related Quality of Life in Patients With Diabetes Mellitus Type 2 on Sulfonylurea Derivatives. - Full Text View

Purpose

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.

Condition
Diabetes Mellitus Type 2

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Perceived Hypoglycemia- and Weight-related Quality of Life of Patients With Sulfonylurea Derivate-treated Diabetes Mellitus Type 2, a Non-interventional Study.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Hypoglycemia

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Hypoglycemic Fear Survey (HFS) questionnaire [ Time Frame: 0 months ] [ Designated as safety issue: No ]
Hypoglycemic Fear Survey (HFS) questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Hypoglycemic Fear Survey (HFS) questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire [ Time Frame: 0 months ] [ Designated as safety issue: No ]
Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Diabetes Symptom Checklist (DSC-R) questionnaire, [ Time Frame: 0 months ] [ Designated as safety issue: No ]
Diabetes Symptom Checklist (DSC-R) questionnaire, [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Diabetes Symptom Checklist (DSC-R) questionnaire, [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Medication Adherence Report Scale (MARS-5) questionnaire [ Time Frame: 0 months ] [ Designated as safety issue: No ]
Medication Adherence Report Scale (MARS-5) questionnaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Medication Adherence Report Scale (MARS-5) questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance [ Time Frame: 0 months ] [ Designated as safety issue: No ]
Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	December 2010
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Patients with Diabetes Mellitus Type 2

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

General practitioners, group practices in primary care, pharmacists

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244646

Locations

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, Netherlands

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:

Prof. F.J. Snoek, PhD

Vrije Universiteit Amsterdam

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01244646 History of Changes
Other Study ID Numbers:	NIS-CNL-DUM-2010/1
Study First Received:	November 18, 2010
Last Updated:	December 5, 2012
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:

Diabetes Mellitus
Type 2
DMT2
T2DM
metformin

sulfonylurea
hypoglycemia
weight
quality of life
compliance

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia

Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013