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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01285076
First received: January 26, 2011
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Other: Other: Retrospective chart review; one participant encounter visit.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects (NEEDS Study)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Achieving Hemoglobin A1C (HbA1C) <7% [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    HbA1c is measured as a percent.

  • Number of Participants With Hypoglycemic Episodes [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Participants self-reported hypoglycemic (low blood sugar) episodes.


Secondary Outcome Measures:
  • Score on the Quality of Life (EQ-5D) Questionnaire [ Time Frame: 1 day (the day of the encounter visit) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 834
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285076

Locations
Taiwan
Merck Sharp & Dohme (I.A.) Corp.
Taipei, Taiwan, 106
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01285076     History of Changes
Other Study ID Numbers: 0431-401
Study First Received: January 26, 2011
Results First Received: December 19, 2013
Last Updated: February 24, 2014
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014