Clinical trial NCT01278485: Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-402)
Official title: Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes complications
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-01-19
Enrollment: 726
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 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.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment
timeFrame: Up to 6 Months Prior to Enrollment
measure: Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment
timeFrame: Up to 6 Months Prior to Enrollment
measure: Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment
timeFrame: Day of Enrollment
Secondary outcomes:
measure: Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment
timeFrame: Day of Enrollment
measure: Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment
timeFrame: Day of Enrollment
measure: Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment
timeFrame: Day of Enrollment
measure: Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment
timeFrame: Day of Enrollment
measure: Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment
timeFrame: Day of Enrollment
measure: Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment
timeFrame: Up to 12 Months Prior to Enrollment
measure: Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment
timeFrame: Up to 12 Months Prior to Enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: