Trial Outcomes & Findings for Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-401) (NCT NCT01285076)

NCT ID: NCT01285076

Last Updated: 2024-05-21

Results Overview

HbA1c is measured as a percent.

• Recruitment status: COMPLETED
• Target enrollment: 834 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-05-21

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	834
Overall Study COMPLETED	834
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-0431-401)

Baseline characteristics by cohort

Measure	All Enrolled Participants n=834 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.
Age, Continuous	65.1 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	362 Participants n=5 Participants
Sex: Female, Male Male	472 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The population analyzed includes only participants with available data.

HbA1c is measured as a percent.

Outcome measures

Measure	All Enrolled Participants n=818 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.
Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%	378 participants

PRIMARY outcome

Timeframe: 6 months

Population: All enrolled participants.

Participants self-reported hypoglycemic (low blood sugar) episodes.

Outcome measures

Measure	All Enrolled Participants n=834 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.
Number of Participants With Hypoglycemic Episodes	258 participants

SECONDARY outcome

Timeframe: 1 day (the day of the encounter visit)

Population: The population analyzed includes only participants with available data.

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).

Outcome measures

Measure	All Enrolled Participants n=823 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.
Score on the Quality of Life (EQ-5D) Questionnaire	74.2 Score on a scale Standard Deviation 14.1

SECONDARY outcome

Timeframe: 1 day (the day of the encounter visit)

Population: All enrolled participants.

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.

Outcome measures

Measure	All Enrolled Participants n=834 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.
Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness scale	67.8 Score on a scale Standard Deviation 11.7
Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) Side effects scale	75.6 Score on a scale Standard Deviation 18.7
Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience scale	73.5 Score on a scale Standard Deviation 12.0
Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) Global satisfaction scale	60.8 Score on a scale Standard Deviation 15.4

SECONDARY outcome

Timeframe: 7 days (during the 7-day period prior to the encounter visit)

Population: All enrolled participants.

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).

Outcome measures

Measure	All Enrolled Participants n=834 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.
Number of Adherence Days on the Self-reported Adherence Questionnaire Followed diabetic diet, n=141	5.5 Days Standard Deviation 2.3
Number of Adherence Days on the Self-reported Adherence Questionnaire Exercise, n=427	5.1 Days Standard Deviation 2.1
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 outcome

Timeframe: 6 months (during the 6-month period prior to the encounter visit)

Population: All enrolled participants.

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.

Outcome measures

Measure	All Enrolled Participants n=834 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.
Experience of Low Blood Sugar (Hypoglycemia) Questionnaire With hypoglycemic symptoms	258 Participants 0.18
Experience of Low Blood Sugar (Hypoglycemia) Questionnaire Mild symptom severity	155 Participants 0.18
Experience of Low Blood Sugar (Hypoglycemia) Questionnaire Moderate symptom severity	32 Participants 0.20
Experience of Low Blood Sugar (Hypoglycemia) Questionnaire Severe symptom severity	47 Participants 0.20
Experience of Low Blood Sugar (Hypoglycemia) Questionnaire Very severe symptom severity	16 Participants 0.15
Experience of Low Blood Sugar (Hypoglycemia) Questionnaire Unknown symptom severity	8 Participants 0.11

SECONDARY outcome

Timeframe: 6 months (during the 6-month period prior to the encounter visit)

Population: The population analyzed includes only participants with available data.

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).

Outcome measures

Measure	All Enrolled Participants n=823 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.
Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II	26.4 Score on a scale Standard Deviation 12.2

SECONDARY outcome

Timeframe: 1 year (during the 12-month period prior to the encounter visit)

Population: The population analyzed includes only participants with available data.

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.

Outcome measures

Measure	All Enrolled Participants n=202 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.
Experience of Weight Gain Questionnaire Wt gain <5 kg	89.6 Percentage of participants
Experience of Weight Gain Questionnaire Wt gain 5-9 kg	6.4 Percentage of participants
Experience of Weight Gain Questionnaire Wt gain 10-15 kg	1.5 Percentage of participants
Experience of Weight Gain Questionnaire Wt gain >15 kg	2.5 Percentage of participants
Experience of Weight Gain Questionnaire Subjective severity of wt gain: very mild, n=122	36.1 Percentage of participants
Experience of Weight Gain Questionnaire Subjective severity of wt gain: mild, n=122	32.0 Percentage of participants
Experience of Weight Gain Questionnaire Subjective severity of wt gain: moderate, n=122	19.7 Percentage of participants
Experience of Weight Gain Questionnaire Subjective severity of wt gain: severe, n=122	9.0 Percentage of participants
Experience of Weight Gain Questionnaire Subjective severity of wt gain: very severe, n=122	3.3 Percentage of participants
Experience of Weight Gain Questionnaire Bothered by wt gain: not at all, n=122	36.1 Percentage of participants
Experience of Weight Gain Questionnaire Bothered by wt gain: a little bit, n=122	27.0 Percentage of participants
Experience of Weight Gain Questionnaire Bothered by wt gain: somewhat, n=122	26.2 Percentage of participants
Experience of Weight Gain Questionnaire Bothered by wt gain: very, n=122	8.2 Percentage of participants
Experience of Weight Gain Questionnaire Bothered by wt gain: extremely, n=122	2.5 Percentage of participants
Experience of Weight Gain Questionnaire Difficulty maintaining wt: not at all, n=122	29.5 Percentage of participants
Experience of Weight Gain Questionnaire Difficulty maintaining wt: a little bit, n=122	25.4 Percentage of participants
Experience of Weight Gain Questionnaire Difficulty maintaining wt: somewhat, n=122	30.3 Percentage of participants
Experience of Weight Gain Questionnaire Difficulty maintaining wt: very, n=122	13.1 Percentage of participants
Experience of Weight Gain Questionnaire Difficulty maintaining wt: extremely, n=122	1.7 Percentage of participants

SECONDARY outcome

Timeframe: 1 year (during the 12-month period prior to the encounter visit)

Population: The population analyzed only includes participants with available data.

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).

Outcome measures

Measure	All Enrolled Participants n=803 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.
Fear of Weight Gain Questionnaire Worried diab tx and wt gain: sometimes; n=799	11.6 Percentage of participants
Fear of Weight Gain Questionnaire Worried about wt gain: never	49.2 Percentage of participants
Fear of Weight Gain Questionnaire Worried about wt gain: rarely	21.3 Percentage of participants
Fear of Weight Gain Questionnaire Worried about wt gain: sometimes	15.7 Percentage of participants
Fear of Weight Gain Questionnaire Worried about wt gain: often	8.2 Percentage of participants
Fear of Weight Gain Questionnaire Worried about wt gain: almost always	5.6 Percentage of participants
Fear of Weight Gain Questionnaire Worried diab tx and wt gain: never; n=799	61.2 Percentage of participants
Fear of Weight Gain Questionnaire Worried diab tx and wt gain: rarely; n=799	20.2 Percentage of participants
Fear of Weight Gain Questionnaire Worried diabetic tx and wt gain: often; n=799	4.4 Percentage of participants
Fear of Weight Gain Questionnaire Worried diab tx and wt gain: almost always; n=799	2.6 Percentage of participants
Fear of Weight Gain Questionnaire Worried not stabilize wt: never; n=799	54.8 Percentage of participants
Fear of Weight Gain Questionnaire Worried not stabilize wt: rarely; n=799	20.9 Percentage of participants
Fear of Weight Gain Questionnaire Worried not stabilize wt: sometimes; n=799	13.3 Percentage of participants
Fear of Weight Gain Questionnaire Worried not stabilize wt: often; n=799	7.5 Percentage of participants
Fear of Weight Gain Questionnaire Worried not stabilize wt: almost always; n=799	3.5 Percentage of participants

SECONDARY outcome

Timeframe: 30 days (during the 30-day period prior to the encounter visit)

Population: All enrolled participants.

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.

Outcome measures

Measure	All Enrolled Participants n=834 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.
Self-reported Barrier Questionnaire Any of the barriers listed below	520 Participants
Self-reported Barrier Questionnaire Barrier: difficulty filling prescriptions	174 Participants
Self-reported Barrier Questionnaire Barrier: unsure about physician instructions	393 Participants
Self-reported Barrier Questionnaire Barrier: unable to follow plan for diabetes	436 Participants
Self-reported Barrier Questionnaire Barrier: bothered by adverse effects	137 Participants

Adverse Events

All Enrolled Participants

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: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator can publish the study results only following the sponsor's review and approval.
• Publication restrictions are in place

Restriction type: OTHER