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Completed

NCT Number: NCT01285076

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Merck Sharp & Dohme (I.A.) Corp.

Taipei, 106, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Other: Retrospective chart review; one participant encounter visit.

Other

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.

Primary outcomes

  1. Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%

    Time frame: 6 months

    HbA1c is measured as a percent.

  2. Number of Participants With Hypoglycemic Episodes

    Time frame: 6 months

    Participants self-reported hypoglycemic (low blood sugar) episodes.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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).

  6. 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.

  7. 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).

  8. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Acronym: NEEDS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2011
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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