Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-401) (NCT01285076) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-401)
Taiwan834 participantsStarted 2011-01-10
Plain-language 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.
Who can participate
Age range
30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%