N/A
N=719
Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-402)
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01278485 ↗Enrolled (actual)
719
Serious AEs
—
Results posted
Aug 2013
Primary outcome: Primary: Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment — 305 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sulphonylurea (Drug); Metformn (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment |
305 | — |
| PRIMARY Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment |
279; 93; 91; 28 | — |
| PRIMARY Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment |
404 | — |
| SECONDARY Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment |
0.89 | — |
| SECONDARY Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment |
72.10 | — |
| SECONDARY Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment |
64.48; 97.18; 67.71; 63.08 | — |
| SECONDARY Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment |
1.54; 4.32; 3.95; 4.85; 4.92 | — |
| SECONDARY Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment |
6.98 | — |
| SECONDARY Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment |
115; 148; 456 | — |
| SECONDARY Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment |
1.18; 0.93; 0.93 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01278485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.