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

Merck Sharp & Dohme LLC1 site in 1 country834 target enrollmentJanuary 10, 2011

ConditionsType 2 Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 834
Locations: 1
Primary Endpoint: Number of Participants With Hypoglycemic Episodes
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 10, 2011

End Date

December 27, 2012

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Number of Participants With Hypoglycemic Episodes

Time Frame: 6 months

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

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

Time Frame: 6 months

HbA1c is measured as a percent.

Secondary Outcomes

Fear of Weight Gain Questionnaire(1 year (during the 12-month period prior to the encounter visit))
Score on the Treatment Satisfaction Questionnaire for Medication (TSQM)(1 day (the day of the encounter visit))
Number of Adherence Days on the Self-reported Adherence Questionnaire(7 days (during the 7-day period prior to the encounter visit))
Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II(6 months (during the 6-month period prior to the encounter visit))
Experience of Weight Gain Questionnaire(1 year (during the 12-month period prior to the encounter visit))
Score on the Quality of Life (EQ-5D) Questionnaire(1 day (the day of the encounter visit))
Experience of Low Blood Sugar (Hypoglycemia) Questionnaire(6 months (during the 6-month period prior to the encounter visit))
Self-reported Barrier Questionnaire(30 days (during the 30-day period prior to the encounter visit))