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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Enrolled Participants | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other: Retrospective chart review; one participant encounter visit. | Other | Participants will be selected based on medical record review in the office of their treating cardiologist, nephrologist, neurologist, or family practice doctor. Participants will have one encounter visit to fill out questionnaires and have a blood draw and recording of weight, blood pressure and waist circumference. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Hemoglobin A1C (HbA1C) <7% | HbA1c is measured as a percent. | 6 months |
| Number of Participants With Hypoglycemic Episodes | Participants self-reported hypoglycemic (low blood sugar) episodes. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Score on the Quality of Life (EQ-5D) Questionnaire | The EQ-5D is a standardised instrument for use as a measure of general health outcome. The EQ-5D contains 5 items to be answered using a 3-point Likert scale plus a Visual Analog Scale (VAS). The EQ-5D covers the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total possible score ranges from 0 (worst) to 100 (best). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merck Sharp & Dohme (I.A.) Corp. | Taipei | 106 | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants | Adults with Type 2 diabetes mellitus (DM) ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Participants | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Achieving Hemoglobin A1C (HbA1C) <7% | HbA1c is measured as a percent. | The population analyzed includes only participants with available data. | Posted | Number | participants | 6 months |
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Up to 24 hours following the encounter visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Enrolled Participants | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 1 day (the day of the encounter visit) |
| Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) | TSQM is a treatment satisfaction questionnaire. The questionnaire consisted of the following dimensions: side effects (4 items), effectiveness (3 items), convenience (3 items) and global satisfaction scale (3 items). Each dimension was measured as a score on a scale. Total possible score ranges from 0 to 100 with a lower score representing a better quality of life. | 1 day (the day of the encounter visit) |
| Number of Adherence Days on the Self-reported Adherence Questionnaire | The self-report adherence questionnaire contains the following items: diabetic diet, exercise, and no missed medication doses during the past week. Total possible score ranges from 0 days (complete non-adherence) to 7 days (complete adherence). | 7 days (during the 7-day period prior to the encounter visit) |
| Experience of Low Blood Sugar (Hypoglycemia) Questionnaire | The experience of low blood sugar questionnaire was developed by the Sponsor to measure the participant's experience of hypoglycemia during the previous 6 months. The questionnaire contains 6 items answered by yes/no or by using a 5-point Likert scale. | 6 months (during the 6-month period prior to the encounter visit) |
| Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II | This questionnaire measures a diabetic participant's fear of hypoglycemia. Items were answered using a 5-point Likert scale; range: 1 (never) to 5 (very often). Total possible scores ranged from 18 (least) to 90 (most). | 6 months (during the 6-month period prior to the encounter visit) |
| Experience of Weight Gain Questionnaire | Participants completed a questionnaire regarding weight (wt) gain during the previous year (measured in kilograms[kg]). The questionnaire contained 4 parts: wt gain, subjective severity of wt gain, bothered by wt gain, and difficulty maintaining wt. Percentages presented below are rounded. | 1 year (during the 12-month period prior to the encounter visit) |
| Fear of Weight Gain Questionnaire | Participants completed a questionnaire regarding their fear of wt gain during the previous year. The questionnaire contained 3 parts: worried about wt gain, worried that diabetic treatment causes wt gain (worried diab tx and wt gain), and worried about not being able to stabilize wt (worried not stabilize wt). | 1 year (during the 12-month period prior to the encounter visit) |
| Self-reported Barrier Questionnaire | The self-report barrier questionnaire contains 4 items: difficulty filling prescriptions, unsure about physician instructions, unable to follow plan for diabetes, and bothered by adverse effects during the prior month. | 30 days (during the 30-day period prior to the encounter visit) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Primary | Number of Participants With Hypoglycemic Episodes | Participants self-reported hypoglycemic (low blood sugar) episodes. | All enrolled participants. | Posted | Number | participants | 6 months |
|
|
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| Secondary | Score on the Quality of Life (EQ-5D) Questionnaire | The EQ-5D is a standardised instrument for use as a measure of general health outcome. The EQ-5D contains 5 items to be answered using a 3-point Likert scale plus a Visual Analog Scale (VAS). The EQ-5D covers the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total possible score ranges from 0 (worst) to 100 (best). | The population analyzed includes only participants with available data. | Posted | Mean | Standard Deviation | Score on a scale | 1 day (the day of the encounter visit) |
|
|
|
| Secondary | Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) | TSQM is a treatment satisfaction questionnaire. The questionnaire consisted of the following dimensions: side effects (4 items), effectiveness (3 items), convenience (3 items) and global satisfaction scale (3 items). Each dimension was measured as a score on a scale. Total possible score ranges from 0 to 100 with a lower score representing a better quality of life. | All enrolled participants. | Posted | Mean | Standard Deviation | Score on a scale | 1 day (the day of the encounter visit) |
|
|
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| Secondary | Number of Adherence Days on the Self-reported Adherence Questionnaire | The self-report adherence questionnaire contains the following items: diabetic diet, exercise, and no missed medication doses during the past week. Total possible score ranges from 0 days (complete non-adherence) to 7 days (complete adherence). | All enrolled participants. | Posted | Mean | Standard Deviation | Days | 7 days (during the 7-day period prior to the encounter visit) |
|
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| Secondary | Experience of Low Blood Sugar (Hypoglycemia) Questionnaire | The experience of low blood sugar questionnaire was developed by the Sponsor to measure the participant's experience of hypoglycemia during the previous 6 months. The questionnaire contains 6 items answered by yes/no or by using a 5-point Likert scale. | All enrolled participants. | Posted | Number | Participants | 6 months (during the 6-month period prior to the encounter visit) |
|
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| Secondary | Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II | This questionnaire measures a diabetic participant's fear of hypoglycemia. Items were answered using a 5-point Likert scale; range: 1 (never) to 5 (very often). Total possible scores ranged from 18 (least) to 90 (most). | The population analyzed includes only participants with available data. | Posted | Mean | Standard Deviation | Score on a scale | 6 months (during the 6-month period prior to the encounter visit) |
|
|
|
| Secondary | Experience of Weight Gain Questionnaire | Participants completed a questionnaire regarding weight (wt) gain during the previous year (measured in kilograms[kg]). The questionnaire contained 4 parts: wt gain, subjective severity of wt gain, bothered by wt gain, and difficulty maintaining wt. Percentages presented below are rounded. | The population analyzed includes only participants with available data. | Posted | Number | Percentage of participants | 1 year (during the 12-month period prior to the encounter visit) |
|
|
|
| Secondary | Fear of Weight Gain Questionnaire | Participants completed a questionnaire regarding their fear of wt gain during the previous year. The questionnaire contained 3 parts: worried about wt gain, worried that diabetic treatment causes wt gain (worried diab tx and wt gain), and worried about not being able to stabilize wt (worried not stabilize wt). | The population analyzed only includes participants with available data. | Posted | Number | Percentage of participants | 1 year (during the 12-month period prior to the encounter visit) |
|
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| Secondary | Self-reported Barrier Questionnaire | The self-report barrier questionnaire contains 4 items: difficulty filling prescriptions, unsure about physician instructions, unable to follow plan for diabetes, and bothered by adverse effects during the prior month. | All enrolled participants. | Posted | Number | Participants | 30 days (during the 30-day period prior to the encounter visit) |
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| 0 |
| 834 |
| 0 |
| 834 |
The investigator can publish the study results only following the sponsor's review and approval.
| D004700 | Endocrine System Diseases |
| Title | Measurements |
|---|---|
|
| Global satisfaction scale |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Severe symptom severity |
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| Very severe symptom severity |
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| Unknown symptom severity |
|
| Title | Measurements |
|---|---|
|
| Wt gain >15 kg |
|
| Subjective severity of wt gain: very mild, n=122 |
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| Subjective severity of wt gain: mild, n=122 |
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| Subjective severity of wt gain: moderate, n=122 |
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| Subjective severity of wt gain: severe, n=122 |
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| Subjective severity of wt gain: very severe, n=122 |
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| Bothered by wt gain: not at all, n=122 |
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| Bothered by wt gain: a little bit, n=122 |
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| Bothered by wt gain: somewhat, n=122 |
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| Bothered by wt gain: very, n=122 |
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| Bothered by wt gain: extremely, n=122 |
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| Difficulty maintaining wt: not at all, n=122 |
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| Difficulty maintaining wt: a little bit, n=122 |
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| Difficulty maintaining wt: somewhat, n=122 |
|
| Difficulty maintaining wt: very, n=122 |
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| Difficulty maintaining wt: extremely, n=122 |
|
| Title | Measurements |
|---|---|
|
| Worried about wt gain: often |
|
| Worried about wt gain: almost always |
|
| Worried diab tx and wt gain: never; n=799 |
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| Worried diab tx and wt gain: rarely; n=799 |
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| Worried diab tx and wt gain: sometimes; n=799 |
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| Worried diabetic tx and wt gain: often; n=799 |
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| Worried diab tx and wt gain: almost always; n=799 |
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| Worried not stabilize wt: never; n=799 |
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| Worried not stabilize wt: rarely; n=799 |
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| Worried not stabilize wt: sometimes; n=799 |
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| Worried not stabilize wt: often; n=799 |
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| Worried not stabilize wt: almost always; n=799 |
|
| Title | Measurements |
|---|---|
|
| Barrier: unable to follow plan for diabetes |
|
| Barrier: bothered by adverse effects |
|