Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes complications
Brief 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.
Interventions
DRUGSulphonylurea
SU administered according to usual practice.
DRUGMetformn
Metformin administered according to usual practice.
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment | Up to 6 Months Prior to Enrollment | The participant experience of low blood sugar (hypoglycemia) questionnaire was used to evaluate participants' experience of hypoglycemia during the previous 6 months. Participants were asked to record whether they experienced hypoglycemia symptoms (yes/no) and to record the severity of those symptoms as mild, moderate, severe, or very severe. |
| Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment | Up to 6 Months Prior to Enrollment | At the time of enrollment, participants were asked to rate their hypoglycemic episodes in the last 6 months as mild, moderate, severe, or very severe. Participants were able to select more than one category. |
| Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment | Day of Enrollment | Participant serum samples were collected after an overnight fast to determine the hemoglobin A1c level. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment | Day of Enrollment | The self-reported adherence and barriers questionnaire to measure treatment compliance asked participants to rate their responses to 5 questions: How often do you take your diabetes medicines exactly as your healthcare provider prescribes them?; During the past 4 weeks, how often were you unsure about some of the things your doctor suggested you do for your diabetes?; During the past 4 weeks, how often were you unable to do what was necessary to follow your doctor's treatment plans for your diabetes?; During the past 4 weeks, how often were you bothered by side effects from your medicines?; and During the past 4 weeks, how often did you have problems getting your prescriptions filled? Participants responded using a scale of 1 to 5, where 1=always, 2=usually, 3=sometimes, 4=rarely, and 5=never. |
| Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment | Day of Enrollment | Fear about hypoglycemia during 6 months prior to enrollment was evaluated using the Worry Scale of the HFS II. Responses to the 18-item questionnaire were recorded on a 0 to 4 scale, with 0=never, 1=rarely, 2=sometimes, 3=often, 4=almost always. The total score ranges from 0 to 72, with higher scores indicating increasing fear of hypoglycemia. |
| Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment | Day of Enrollment | The EQ-5D is a questionnaire that assesses participant quality of life in 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 levels: no problems, some problems, extreme problems for which participants are asked to self-rate their experience. The EQ-5D total score ranges from -0.171 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. |
| Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment | Up to 12 Months Prior to Enrollment | On the day of enrollment, participants were asked to rate their fear of gaining weight in the 12 months prior to enrollment using a self-administered questionnaire. The questionnaire elicited responses to 3 statements (I worry about gaining weight; I worry that my diabetic treatment makes me gain weight; and I worry about not being able to stabilize my weight) and relied on a scale of 0 to 4, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=almost always. |
| Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment | Up to 12 Months Prior to Enrollment | Participants were asked to rate their weight change experience in the 12 months prior to enrollment as: weight increased, weight decreased, or weight remained stable. |
| Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment | Day of Enrollment | Participant health status was self-reported in 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and was analyzed by using visual analog scale (VAS) which records participant responses on a scale of 0 (poor health) to 100 (excellent health). |
| Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment | Day of Enrollment | The TSQM is a treatment satisfaction questionnaire containing 14 items covering the following dimensions: side effects, effectiveness, convenience, and global satisfaction. Participants were asked to respond in a yes or no fashion, or by using a 5- or 7-point Likert scale. The score for each dimension ranges from 0 to 100, with a higher score expressing a better quality of life. |
Participant flow
Recruitment details
This study enrolled a total of 726 Korean participants who had been treated with sulfonylurea monotherapy or sulfonylurea and metformin combination therapy for at least six months in the departments of Cardiology, Nephrology, and Family Medicine of various Korean hospitals and medical centers.
Pre-assignment details
Seven participants who failed to meet all the inclusion criteria were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age Adults with Type 2 diabetes mellitus ≥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, or family practice doctor. | 719 |
| Total | 719 |
Baseline characteristics
| Characteristic | Adults With Type 2 Diabetes Mellitus ≥30 Years of Age |
|---|---|
| Age, Continuous | 65.91 years STANDARD_DEVIATION 9.98 |
| Sex: Female, Male Female | 319 Participants |
| Sex: Female, Male Male | 400 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment
The participant experience of low blood sugar (hypoglycemia) questionnaire was used to evaluate participants' experience of hypoglycemia during the previous 6 months. Participants were asked to record whether they experienced hypoglycemia symptoms (yes/no) and to record the severity of those symptoms as mild, moderate, severe, or very severe.
Time frame: Up to 6 Months Prior to Enrollment
Population: All enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment | 305 Participants |
Primary
Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment
At the time of enrollment, participants were asked to rate their hypoglycemic episodes in the last 6 months as mild, moderate, severe, or very severe. Participants were able to select more than one category.
Time frame: Up to 6 Months Prior to Enrollment
Population: All enrolled participants that experienced hypoglycemia in the prior 6 months.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment | Mild | 279 Participants |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment | Moderate | 93 Participants |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment | Severe | 91 Participants |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment | Very Severe | 28 Participants |
Primary
Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment
Participant serum samples were collected after an overnight fast to determine the hemoglobin A1c level. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.
Time frame: Day of Enrollment
Population: All enrolled participants with a hemoglobin A1c measurement collected on the day of enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment | 404 Participants |
Secondary
Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment
Participants were asked to rate their weight change experience in the 12 months prior to enrollment as: weight increased, weight decreased, or weight remained stable.
Time frame: Up to 12 Months Prior to Enrollment
Population: All enrolled participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment | Gained Weight | 115 Participants |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment | Lost Weight | 148 Participants |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment | Weight Remained Stable | 456 Participants |
Secondary
Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment
On the day of enrollment, participants were asked to rate their fear of gaining weight in the 12 months prior to enrollment using a self-administered questionnaire. The questionnaire elicited responses to 3 statements (I worry about gaining weight; I worry that my diabetic treatment makes me gain weight; and I worry about not being able to stabilize my weight) and relied on a scale of 0 to 4, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=almost always.
Time frame: Up to 12 Months Prior to Enrollment
Population: All enrolled participants that completed the fear of weight gain questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment | Worries About Gaining Weight | 1.18 Score on a Scale | Standard Deviation 1.36 |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment | Worries Diabetic Treatment Causes Weight Gain | 0.93 Score on a Scale | Standard Deviation 1.26 |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment | Worries About Inability to Stabilize Weight | 0.93 Score on a Scale | Standard Deviation 1.26 |
Secondary
Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment
The EQ-5D is a questionnaire that assesses participant quality of life in 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 levels: no problems, some problems, extreme problems for which participants are asked to self-rate their experience. The EQ-5D total score ranges from -0.171 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.
Time frame: Day of Enrollment
Population: All enrolled participants with a completed EQ-5D questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment | 0.89 Score on a Scale | Standard Deviation 0.14 |
Secondary
Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment
Participant health status was self-reported in 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and was analyzed by using visual analog scale (VAS) which records participant responses on a scale of 0 (poor health) to 100 (excellent health).
Time frame: Day of Enrollment
Population: All enrolled participants with a completed EQ-VAS questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment | 72.10 Score on a Scale | Standard Deviation 16.68 |
Secondary
Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment
The self-reported adherence and barriers questionnaire to measure treatment compliance asked participants to rate their responses to 5 questions: How often do you take your diabetes medicines exactly as your healthcare provider prescribes them?; During the past 4 weeks, how often were you unsure about some of the things your doctor suggested you do for your diabetes?; During the past 4 weeks, how often were you unable to do what was necessary to follow your doctor's treatment plans for your diabetes?; During the past 4 weeks, how often were you bothered by side effects from your medicines?; and During the past 4 weeks, how often did you have problems getting your prescriptions filled? Participants responded using a scale of 1 to 5, where 1=always, 2=usually, 3=sometimes, 4=rarely, and 5=never.
Time frame: Day of Enrollment
Population: All enrolled participants that completed a questionnaire on the day of enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment | Takes Medicine Exactly As Prescribed (n=719) | 1.54 Score on a Scale | Standard Deviation 0.81 |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment | Unsure About Treatment Plan Last 4 Weeks (n=719) | 4.32 Score on a Scale | Standard Deviation 1.1 |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment | Followed Treatment Plan Last 4 Weeks (n=718) | 3.95 Score on a Scale | Standard Deviation 1.14 |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment | Problems With Side Effects Last 4 Weeks (n=711) | 4.85 Score on a Scale | Standard Deviation 0.53 |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment | Problem Filling Prescriptions Last 4 Weeks (n=719) | 4.92 Score on a Scale | Standard Deviation 0.43 |
Secondary
Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment
The TSQM is a treatment satisfaction questionnaire containing 14 items covering the following dimensions: side effects, effectiveness, convenience, and global satisfaction. Participants were asked to respond in a yes or no fashion, or by using a 5- or 7-point Likert scale. The score for each dimension ranges from 0 to 100, with a higher score expressing a better quality of life.
Time frame: Day of Enrollment
Population: All enrolled participants that completed the TSQM on the day of enrollment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment | Effectiveness | 64.48 Score on a Scale | Standard Deviation 12.96 |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment | Side Effects | 97.18 Score on a Scale | Standard Deviation 10.63 |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment | Convenience | 67.71 Score on a Scale | Standard Deviation 13.38 |
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment | Global Satisfaction | 63.08 Score on a Scale | Standard Deviation 14.46 |
Secondary
Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment
Fear about hypoglycemia during 6 months prior to enrollment was evaluated using the Worry Scale of the HFS II. Responses to the 18-item questionnaire were recorded on a 0 to 4 scale, with 0=never, 1=rarely, 2=sometimes, 3=often, 4=almost always. The total score ranges from 0 to 72, with higher scores indicating increasing fear of hypoglycemia.
Time frame: Day of Enrollment
Population: All enrolled participants that completed the worry scale of the HFS II.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adults With Type 2 Diabetes Mellitus ≥30 Years of Age | Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment | 6.98 Score on a Scale | Standard Deviation 11.27 |