Clinical trial NCT01285076: Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-401)
Official title: Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects (NEEDS Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-01-27
Enrollment: 834
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%
timeFrame: 6 months
measure: Number of Participants With Hypoglycemic Episodes
timeFrame: 6 months
Secondary outcomes:
measure: Score on the Quality of Life (EQ-5D) Questionnaire
timeFrame: 1 day (the day of the encounter visit)
measure: Score on the Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: 1 day (the day of the encounter visit)
measure: Number of Adherence Days on the Self-reported Adherence Questionnaire
timeFrame: 7 days (during the 7-day period prior to the encounter visit)
measure: Experience of Low Blood Sugar (Hypoglycemia) Questionnaire
timeFrame: 6 months (during the 6-month period prior to the encounter visit)
measure: Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II
timeFrame: 6 months (during the 6-month period prior to the encounter visit)
measure: Experience of Weight Gain Questionnaire
timeFrame: 1 year (during the 12-month period prior to the encounter visit)
measure: Fear of Weight Gain Questionnaire
timeFrame: 1 year (during the 12-month period prior to the encounter visit)
measure: Self-reported Barrier Questionnaire
timeFrame: 30 days (during the 30-day period prior to the encounter visit)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Merck Sharp & Dohme (I.A.) Corp.
Study officials:
References: