Trial Outcomes & Findings for Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-402) (NCT NCT01278485)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

726 participants

Primary outcome timeframe

Up to 6 Months Prior to Enrollment

Results posted on

2015-07-28

Participant Flow

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.

Seven participants who failed to meet all the inclusion criteria were excluded from the study.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	719
Overall Study COMPLETED	719
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-402)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adults With Type 2 Diabetes Mellitus ≥30 Years of Age n=719 Participants 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.
Age, Continuous	65.91 years STANDARD_DEVIATION 9.98 • n=5 Participants
Sex: Female, Male Female	319 Participants n=5 Participants
Sex: Female, Male Male	400 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 Months Prior to Enrollment

Population: All enrolled participants.

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.

Outcome measures

Outcome measures
Measure	Adults With Type 2 Diabetes Mellitus ≥30 Years of Age n=719 Participants 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.
Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment	305 Participants

PRIMARY outcome

Timeframe: Up to 6 Months Prior to Enrollment

Population: All enrolled participants that experienced hypoglycemia in the prior 6 months.

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.

Outcome measures

Outcome measures
Measure	Adults With Type 2 Diabetes Mellitus ≥30 Years of Age n=305 Participants 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.
Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment Mild	279 Participants
Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment Moderate	93 Participants
Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment Severe	91 Participants
Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment Very Severe	28 Participants

PRIMARY outcome

Timeframe: Day of Enrollment

Population: All enrolled participants with a hemoglobin A1c measurement collected on the 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.

Outcome measures

Outcome measures
Measure	Adults With Type 2 Diabetes Mellitus ≥30 Years of Age n=717 Participants 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.
Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment	404 Participants

SECONDARY outcome

Timeframe: Day of Enrollment

Population: All enrolled participants with a completed EQ-5D questionnaire.

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.

Outcome measures

Outcome measures
Measure	Adults With Type 2 Diabetes Mellitus ≥30 Years of Age n=714 Participants 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.
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 outcome

Timeframe: Day of Enrollment

Population: All enrolled participants with a completed EQ-VAS questionnaire.

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).

Outcome measures

Outcome measures
Measure	Adults With Type 2 Diabetes Mellitus ≥30 Years of Age n=714 Participants 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.
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 outcome

Timeframe: Day of Enrollment

Population: All enrolled participants that completed the TSQM on the 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.

Outcome measures

Outcome measures
Measure	Adults With Type 2 Diabetes Mellitus ≥30 Years of Age n=716 Participants 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.
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
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
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
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 outcome

Timeframe: Day of Enrollment

Population: All enrolled participants that completed a questionnaire on the 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.

Outcome measures

Outcome measures
Measure	Adults With Type 2 Diabetes Mellitus ≥30 Years of Age n=719 Participants 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.
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 1.10
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
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
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
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 outcome

Timeframe: Day of Enrollment

Population: All enrolled participants that completed the worry scale of the HFS II.

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.

Outcome measures

Outcome measures
Measure	Adults With Type 2 Diabetes Mellitus ≥30 Years of Age n=709 Participants 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.
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

SECONDARY outcome

Timeframe: Up to 12 Months Prior to Enrollment

Population: All enrolled participants

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.

Outcome measures

Outcome measures
Measure	Adults With Type 2 Diabetes Mellitus ≥30 Years of Age n=719 Participants 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.
Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment Gained Weight	115 Participants
Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment Lost Weight	148 Participants
Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment Weight Remained Stable	456 Participants

SECONDARY outcome

Timeframe: Up to 12 Months Prior to Enrollment

Population: All enrolled participants that completed the fear of weight gain questionnaire.

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.

Outcome measures

Outcome measures
Measure	Adults With Type 2 Diabetes Mellitus ≥30 Years of Age n=716 Participants 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.
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
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
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

Adverse Events

Adults With Type 2 Diabetes Mellitus ≥30 Years of Age

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place