Text Size

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
ClinicalTrials.gov Identifier:
NCT01278485
First received: January 13, 2011
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  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 (DM) 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.


Condition Intervention
Type 2 Diabetes
 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of hypoglycemic episodes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of participants achieving HbA1C <7% [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Score on the Quality of Life (EQ-5D/EQ-VAS) Questionnaire [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Score on the Self-report Adherence and Barriers Questionnaire [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Score on the Experience of Low Blood Sugar (Hypoglycemia) Questionnaire [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Score on the Experience of Weight Gain Questionnaire [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Score on the Fear of Weight Gain Questionnaire [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

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
Adults with Type 2 diabetes mellitus ≥30 years of age
Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
 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, 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 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
Investigators
Principal Investigator: SangHong Baek The Catholic University of Korea, St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01278485     History of Changes
Other Study ID Numbers: 0431-402
Study First Received: January 13, 2011
Last Updated: August 6, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Merck:
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 May 19, 2013