N/A
N=834
Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-401)
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01285076 ↗Enrolled (actual)
834
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Number of Participants Achieving Hemoglobin A1C (HbA1C) <7% — 378 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Other: Retrospective chart review; one participant encounter visit. (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Hemoglobin A1C (HbA1C) <7% |
378 | — |
| PRIMARY Number of Participants With Hypoglycemic Episodes |
258 | — |
| SECONDARY Score on the Quality of Life (EQ-5D) Questionnaire |
74.2 | — |
| SECONDARY Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) |
67.8; 75.6; 73.5; 60.8 | — |
| SECONDARY Number of Adherence Days on the Self-reported Adherence Questionnaire |
5.5; 5.1; 6.7 | — |
| SECONDARY Experience of Low Blood Sugar (Hypoglycemia) Questionnaire |
258; 155; 32; 47; 16; 8 | — |
| SECONDARY Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II |
26.4 | — |
| SECONDARY Experience of Weight Gain Questionnaire |
89.6; 6.4; 1.5; 2.5; 36.1; 32.0 | — |
| SECONDARY Fear of Weight Gain Questionnaire |
49.2; 21.3; 15.7; 8.2; 5.6; 61.2 | — |
| SECONDARY Self-reported Barrier Questionnaire |
520; 174; 393; 436; 137 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01285076). 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.