Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-401) (NEEDS)
|ClinicalTrials.gov Identifier: NCT01285076|
Recruitment Status : Completed
First Posted : January 27, 2011
Results First Posted : March 24, 2014
Last Update Posted : February 16, 2015
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Mellitus||Other: Other: Retrospective chart review; one participant encounter visit.|
|Study Type :||Observational|
|Actual Enrollment :||834 participants|
|Official Title:||Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects (NEEDS Study)|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
All Enrolled Participants
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.
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.
- Number of Participants Achieving Hemoglobin A1C (HbA1C) <7% [ Time Frame: 6 months ]HbA1c is measured as a percent.
- Number of Participants With Hypoglycemic Episodes [ Time Frame: 6 months ]Participants self-reported hypoglycemic (low blood sugar) episodes.
- Score on the Quality of Life (EQ-5D) Questionnaire [ Time Frame: 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).
- Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 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 [ Time Frame: 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).
- Experience of Low Blood Sugar (Hypoglycemia) Questionnaire [ Time Frame: 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.
- Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II [ Time Frame: 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).
- Experience of Weight Gain Questionnaire [ Time Frame: 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 [ Time Frame: 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).
- Self-reported Barrier Questionnaire [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285076
|Merck Sharp & Dohme (I.A.) Corp.|
|Taipei, Taiwan, 106|