Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-401)

Completed

Conditions: Type 2 Diabetes Mellitus

Registration Number: NCT01285076

Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 834

Inclusion Criteria

Participants diagnosed with Type 2 DM.
Participants at least 30 years of age at time of Type 2 DM diagnosis.
Participants treated with SU monotherapy or SU + MF combination therapy for at least 6 months prior to enrollment.
Participants receiving diabetes care from a cardiologist, nephrologist, neurologist, or family practice doctor for at least 6 months.
Participants with a clinical record in the health care center.
Participants in whose medical records a minimum core data set can be found; core data defined as: age, gender, duration of diabetes/age at diagnosis, all glucose-lowering medications (branded and generic names, dosage, dosing frequency, starting and stopping dates) since the start of all antihyperglycemic medications.

Exclusion Criteria

Participants with Type 1 DM.
Participants who are pregnant or with gestational DM.
Participants receiving any anti-diabetic treatment from an endocrinologist/diabetologist in the previous 6 months.
Participants requiring daily concomitant usage of insulin.
Participants receiving any oral diabetes medications other than SU or SU + MF.
Participants who are already participating in a clinical trial or other clinical study.
Participants for whom it would be impossible to complete the questionnaire.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Hypoglycemic Episodes	6 months	Participants self-reported hypoglycemic (low blood sugar) episodes.
Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%	6 months	HbA1c is measured as a percent.

Secondary Outcome Measures

Name	Time	Method
Experience of Weight Gain Questionnaire	1 year (during the 12-month period prior to the encounter visit)	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.
Fear of Weight Gain Questionnaire	1 year (during the 12-month period prior to the encounter visit)	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).
Score on the Treatment Satisfaction Questionnaire for Medication (TSQM)	1 day (the day of the encounter visit)	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.
Number of Adherence Days on the Self-reported Adherence Questionnaire	7 days (during the 7-day period prior to the encounter visit)	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).
Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II	6 months (during the 6-month period prior to the encounter visit)	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).
Score on the Quality of Life (EQ-5D) Questionnaire	1 day (the day of the encounter visit)	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).
Experience of Low Blood Sugar (Hypoglycemia) Questionnaire	6 months (during the 6-month period prior to the encounter visit)	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.
Self-reported Barrier Questionnaire	30 days (during the 30-day period prior to the encounter visit)	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.