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

Study Overview
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Brief Summary
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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.

Official Title
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Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects (NEEDS Study)

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Other: Retrospective chart review; one participant encounter visit.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Enrolled Participants<br>Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor. | Other: Other: Retrospective chart review; one participant encounter visit.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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). | 7 days (during the 7-day period prior to the encounter visit) | 
| Experience of Low Blood Sugar (Hypoglycemia) Questionnaire | 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. | 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). | 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. | 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). | 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. | 30 days (during the 30-day period prior to the encounter visit) |