Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-402) (NEEDS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01278485
First received: January 13, 2011
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

This is a multicenter, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with type 2 diabetes mellitus (T2DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy by their cardiologist, nephrologist, or family practice doctor for at least 6 months prior to study enrollment.

The purpose of the study is to assess treatment patterns, goal attainment rates, long-term diabetes complication rates, and frequency and severity of hypoglycemic episodes among T2DM participants treated in cardiology, nephrology and family practice settings.


Condition Intervention
Type 2 Diabetes Mellitus
Drug: Sulphonylurea
Drug: Metformn

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment [ Time Frame: Up to 6 Months Prior to Enrollment ] [ Designated as safety issue: No ]
    The participant experience of low blood sugar (hypoglycemia) questionnaire was used to evaluate participants' experience of hypoglycemia during the previous 6 months. Participants were asked to record whether they experienced hypoglycemia symptoms (yes/no) and to record the severity of those symptoms as mild, moderate, severe, or very severe.

  • Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment [ Time Frame: Up to 6 Months Prior to Enrollment ] [ Designated as safety issue: No ]
    At the time of enrollment, participants were asked to rate their hypoglycemic episodes in the last 6 months as mild, moderate, severe, or very severe. Participants were able to select more than one category.

  • Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment [ Time Frame: Day of Enrollment ] [ Designated as safety issue: No ]
    Participant serum samples were collected after an overnight fast to determine the hemoglobin A1c level. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.


Secondary Outcome Measures:
  • Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment [ Time Frame: Day of Enrollment ] [ Designated as safety issue: No ]
    The EQ-5D is a questionnaire that assesses participant quality of life in 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 levels: no problems, some problems, extreme problems for which participants are asked to self-rate their experience. The EQ-5D total score ranges from -0.171 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.

  • Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment [ Time Frame: Day of Enrollment ] [ Designated as safety issue: No ]
    Participant health status was self-reported in 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and was analyzed by using visual analog scale (VAS) which records participant responses on a scale of 0 (poor health) to 100 (excellent health).

  • Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment [ Time Frame: Day of Enrollment ] [ Designated as safety issue: No ]
    The TSQM is a treatment satisfaction questionnaire containing 14 items covering the following dimensions: side effects, effectiveness, convenience, and global satisfaction. Participants were asked to respond in a yes or no fashion, or by using a 5- or 7-point Likert scale. The score for each dimension ranges from 0 to 100, with a higher score expressing a better quality of life.

  • Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment [ Time Frame: Day of Enrollment ] [ Designated as safety issue: No ]
    The self-reported adherence and barriers questionnaire to measure treatment compliance asked participants to rate their responses to 5 questions: How often do you take your diabetes medicines exactly as your healthcare provider prescribes them?; During the past 4 weeks, how often were you unsure about some of the things your doctor suggested you do for your diabetes?; During the past 4 weeks, how often were you unable to do what was necessary to follow your doctor's treatment plans for your diabetes?; During the past 4 weeks, how often were you bothered by side effects from your medicines?; and During the past 4 weeks, how often did you have problems getting your prescriptions filled? Participants responded using a scale of 1 to 5, where 1=always, 2=usually, 3=sometimes, 4=rarely, and 5=never.

  • Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment [ Time Frame: Day of Enrollment ] [ Designated as safety issue: No ]
    Fear about hypoglycemia during 6 months prior to enrollment was evaluated using the Worry Scale of the HFS II. Responses to the 18-item questionnaire were recorded on a 0 to 4 scale, with 0=never, 1=rarely, 2=sometimes, 3=often, 4=almost always. The total score ranges from 0 to 72, with higher scores indicating increasing fear of hypoglycemia.

  • Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment [ Time Frame: Up to 12 Months Prior to Enrollment ] [ Designated as safety issue: No ]
    Participants were asked to rate their weight change experience in the 12 months prior to enrollment as: weight increased, weight decreased, or weight remained stable.

  • Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment [ Time Frame: Up to 12 Months Prior to Enrollment ] [ Designated as safety issue: No ]
    On the day of enrollment, participants were asked to rate their fear of gaining weight in the 12 months prior to enrollment using a self-administered questionnaire. The questionnaire elicited responses to 3 statements (I worry about gaining weight; I worry that my diabetic treatment makes me gain weight; and I worry about not being able to stabilize my weight) and relied on a scale of 0 to 4, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=almost always.


Enrollment: 726
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sulphonylurea (SU) Monotherapy or SU + Metformin
Participants with Type 2 diabetes that have been treated with SU monotherapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
Drug: Sulphonylurea
SU administered according to usual practice.
Drug: Metformn
Metformin administered according to usual practice.

  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 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ merformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.

Criteria

Inclusion Criteria

  • Participants diagnosed with type 2 diabetes mellitus (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 or family practitioner 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 other 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: NCT01278485

Locations
Korea, Republic of
MSD Korea Ltd.
Seoul, Korea, Republic of, 121-705
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Chang Kyu Park Korea University Guro Hospital
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01278485     History of Changes
Other Study ID Numbers: 0431-402
Study First Received: January 13, 2011
Results First Received: May 14, 2013
Last Updated: February 18, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Merck Sharp & Dohme Corp.:
Diabetes complications

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 23, 2014