This is a multi-center, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with Type 2 diabetes mellitus (DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy by their cardiologist, nephrologist, neurologist, or family practice doctor for at least 6 months prior to Study Enrollment.
Study Type
OBSERVATIONAL
Enrollment
834
Participants will be selected based on medical record review in the office of their treating cardiologist, nephrologist, neurologist, or family practice doctor. Participants will have one encounter visit to fill out questionnaires and have a blood draw and recording of weight, blood pressure and waist circumference.
Merck Sharp & Dohme (I.A.) Corp.
Taipei, Taiwan
Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%
HbA1c is measured as a percent.
Time frame: 6 months
Number of Participants With Hypoglycemic Episodes
Participants self-reported hypoglycemic (low blood sugar) episodes.
Time frame: 6 months
Score on the Quality of Life (EQ-5D) Questionnaire
The EQ-5D is a standardised instrument for use as a measure of general health outcome. The EQ-5D contains 5 items to be answered using a 3-point Likert scale plus a Visual Analog Scale (VAS). The EQ-5D covers the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total possible score ranges from 0 (worst) to 100 (best).
Time frame: 1 day (the day of the encounter visit)
Score on the Treatment Satisfaction Questionnaire for Medication (TSQM)
TSQM is a treatment satisfaction questionnaire. The questionnaire consisted of the following dimensions: side effects (4 items), effectiveness (3 items), convenience (3 items) and global satisfaction scale (3 items). Each dimension was measured as a score on a scale. Total possible score ranges from 0 to 100 with a lower score representing a better quality of life.
Time frame: 1 day (the day of the encounter visit)
Number of Adherence Days on the Self-reported Adherence Questionnaire
The self-report adherence questionnaire contains the following items: diabetic diet, exercise, and no missed medication doses during the past week. Total possible score ranges from 0 days (complete non-adherence) to 7 days (complete adherence).
Time frame: 7 days (during the 7-day period prior to the encounter visit)
Experience of Low Blood Sugar (Hypoglycemia) Questionnaire
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The experience of low blood sugar questionnaire was developed by the Sponsor to measure the participant's experience of hypoglycemia during the previous 6 months. The questionnaire contains 6 items answered by yes/no or by using a 5-point Likert scale.
Time frame: 6 months (during the 6-month period prior to the encounter visit)
Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II
This questionnaire measures a diabetic participant's fear of hypoglycemia. Items were answered using a 5-point Likert scale; range: 1 (never) to 5 (very often). Total possible scores ranged from 18 (least) to 90 (most).
Time frame: 6 months (during the 6-month period prior to the encounter visit)
Experience of Weight Gain Questionnaire
Participants completed a questionnaire regarding weight (wt) gain during the previous year (measured in kilograms\[kg\]). The questionnaire contained 4 parts: wt gain, subjective severity of wt gain, bothered by wt gain, and difficulty maintaining wt. Percentages presented below are rounded.
Time frame: 1 year (during the 12-month period prior to the encounter visit)
Fear of Weight Gain Questionnaire
Participants completed a questionnaire regarding their fear of wt gain during the previous year. The questionnaire contained 3 parts: worried about wt gain, worried that diabetic treatment causes wt gain (worried diab tx and wt gain), and worried about not being able to stabilize wt (worried not stabilize wt).
Time frame: 1 year (during the 12-month period prior to the encounter visit)
Self-reported Barrier Questionnaire
The self-report barrier questionnaire contains 4 items: difficulty filling prescriptions, unsure about physician instructions, unable to follow plan for diabetes, and bothered by adverse effects during the prior month.
Time frame: 30 days (during the 30-day period prior to the encounter visit)