Type 2 Diabetes Mellitus
Conditions
Brief 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.
Interventions
OTHEROther: Retrospective chart review; one participant encounter visit.
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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Hemoglobin A1C (HbA1C) <7% | 6 months | HbA1c is measured as a percent. |
| Number of Participants With Hypoglycemic Episodes | 6 months | Participants self-reported hypoglycemic (low blood sugar) episodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adherence Days on the Self-reported Adherence Questionnaire | 7 days (during the 7-day period prior to the encounter visit) | 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). |
| Experience of Low Blood Sugar (Hypoglycemia) Questionnaire | 6 months (during the 6-month period prior to the encounter visit) | 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. |
| Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II | 6 months (during the 6-month period prior to the encounter visit) | 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). |
| Score on the Quality of Life (EQ-5D) Questionnaire | 1 day (the day of the encounter visit) | 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). |
| Fear of Weight Gain Questionnaire | 1 year (during the 12-month period prior to the encounter visit) | 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). |
| Self-reported Barrier Questionnaire | 30 days (during the 30-day period prior to the encounter visit) | 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. |
| Experience of Weight Gain Questionnaire | 1 year (during the 12-month period prior to the encounter visit) | 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. |
| Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) | 1 day (the day of the encounter visit) | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 834 |
| Total | 834 |
Baseline characteristics
| Characteristic | All Enrolled Participants |
|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 362 Participants |
| Sex: Female, Male Male | 472 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 834 |
| serious Total, serious adverse events | 0 / 834 |
Outcome results
Primary
Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%
HbA1c is measured as a percent.
Time frame: 6 months
Population: The population analyzed includes only participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Enrolled Participants | Number of Participants Achieving Hemoglobin A1C (HbA1C) <7% | 378 participants |
Primary
Number of Participants With Hypoglycemic Episodes
Participants self-reported hypoglycemic (low blood sugar) episodes.
Time frame: 6 months
Population: All enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Enrolled Participants | Number of Participants With Hypoglycemic Episodes | 258 participants |
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.
Time frame: 6 months (during the 6-month period prior to the encounter visit)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| All Enrolled Participants | Experience of Low Blood Sugar (Hypoglycemia) Questionnaire | With hypoglycemic symptoms | 258 Participants | 0.18 |
| All Enrolled Participants | Experience of Low Blood Sugar (Hypoglycemia) Questionnaire | Mild symptom severity | 155 Participants | 0.18 |
| All Enrolled Participants | Experience of Low Blood Sugar (Hypoglycemia) Questionnaire | Moderate symptom severity | 32 Participants | 0.2 |
| All Enrolled Participants | Experience of Low Blood Sugar (Hypoglycemia) Questionnaire | Severe symptom severity | 47 Participants | 0.2 |
| All Enrolled Participants | Experience of Low Blood Sugar (Hypoglycemia) Questionnaire | Very severe symptom severity | 16 Participants | 0.15 |
| All Enrolled Participants | Experience of Low Blood Sugar (Hypoglycemia) Questionnaire | Unknown symptom severity | 8 Participants | 0.11 |
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.
Time frame: 1 year (during the 12-month period prior to the encounter visit)
Population: The population analyzed includes only participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Wt gain <5 kg | 89.6 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Wt gain 5-9 kg | 6.4 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Wt gain 10-15 kg | 1.5 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Wt gain >15 kg | 2.5 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Subjective severity of wt gain: very mild, n=122 | 36.1 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Subjective severity of wt gain: mild, n=122 | 32.0 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Subjective severity of wt gain: moderate, n=122 | 19.7 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Subjective severity of wt gain: severe, n=122 | 9.0 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Subjective severity of wt gain: very severe, n=122 | 3.3 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Bothered by wt gain: not at all, n=122 | 36.1 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Bothered by wt gain: a little bit, n=122 | 27.0 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Bothered by wt gain: somewhat, n=122 | 26.2 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Bothered by wt gain: very, n=122 | 8.2 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Bothered by wt gain: extremely, n=122 | 2.5 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Difficulty maintaining wt: not at all, n=122 | 29.5 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Difficulty maintaining wt: a little bit, n=122 | 25.4 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Difficulty maintaining wt: somewhat, n=122 | 30.3 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Difficulty maintaining wt: very, n=122 | 13.1 Percentage of participants |
| All Enrolled Participants | Experience of Weight Gain Questionnaire | Difficulty maintaining wt: extremely, n=122 | 1.7 Percentage of participants |
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).
Time frame: 1 year (during the 12-month period prior to the encounter visit)
Population: The population analyzed only includes participants with available data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried about wt gain: never | 49.2 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried about wt gain: rarely | 21.3 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried about wt gain: sometimes | 15.7 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried about wt gain: often | 8.2 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried about wt gain: almost always | 5.6 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried diab tx and wt gain: never; n=799 | 61.2 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried diab tx and wt gain: rarely; n=799 | 20.2 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried diab tx and wt gain: sometimes; n=799 | 11.6 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried diabetic tx and wt gain: often; n=799 | 4.4 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried diab tx and wt gain: almost always; n=799 | 2.6 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried not stabilize wt: never; n=799 | 54.8 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried not stabilize wt: rarely; n=799 | 20.9 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried not stabilize wt: sometimes; n=799 | 13.3 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried not stabilize wt: often; n=799 | 7.5 Percentage of participants |
| All Enrolled Participants | Fear of Weight Gain Questionnaire | Worried not stabilize wt: almost always; n=799 | 3.5 Percentage of participants |
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).
Time frame: 7 days (during the 7-day period prior to the encounter visit)
Population: All enrolled participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Participants | Number of Adherence Days on the Self-reported Adherence Questionnaire | Followed diabetic diet, n=141 | 5.5 Days | Standard Deviation 2.3 |
| All Enrolled Participants | Number of Adherence Days on the Self-reported Adherence Questionnaire | Exercise, n=427 | 5.1 Days | Standard Deviation 2.1 |
| All Enrolled Participants | Number of Adherence Days on the Self-reported Adherence Questionnaire | No missed doses of medication, n=817 | 6.7 Days | Standard Deviation 1.1 |
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).
Time frame: 1 day (the day of the encounter visit)
Population: The population analyzed includes only participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Enrolled Participants | Score on the Quality of Life (EQ-5D) Questionnaire | 74.2 Score on a scale | Standard Deviation 14.1 |
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.
Time frame: 1 day (the day of the encounter visit)
Population: All enrolled participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Participants | Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) | Effectiveness scale | 67.8 Score on a scale | Standard Deviation 11.7 |
| All Enrolled Participants | Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) | Side effects scale | 75.6 Score on a scale | Standard Deviation 18.7 |
| All Enrolled Participants | Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) | Convenience scale | 73.5 Score on a scale | Standard Deviation 12 |
| All Enrolled Participants | Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) | Global satisfaction scale | 60.8 Score on a scale | Standard Deviation 15.4 |
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).
Time frame: 6 months (during the 6-month period prior to the encounter visit)
Population: The population analyzed includes only participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Enrolled Participants | Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II | 26.4 Score on a scale | Standard Deviation 12.2 |
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.
Time frame: 30 days (during the 30-day period prior to the encounter visit)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Participants | Self-reported Barrier Questionnaire | Any of the barriers listed below | 520 Participants |
| All Enrolled Participants | Self-reported Barrier Questionnaire | Barrier: difficulty filling prescriptions | 174 Participants |
| All Enrolled Participants | Self-reported Barrier Questionnaire | Barrier: unsure about physician instructions | 393 Participants |
| All Enrolled Participants | Self-reported Barrier Questionnaire | Barrier: unable to follow plan for diabetes | 436 Participants |
| All Enrolled Participants | Self-reported Barrier Questionnaire | Barrier: bothered by adverse effects | 137 Participants |