Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-401)

NCT01285076 | Completed Results

• 1 other identifier: 0431-401
• Study Type: observational
• Target: 834
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Score on the Quality of Life (EQ-5D) Questionnaire

  1 day (the day of the encounter visit)

• Score on the Treatment Satisfaction Questionnaire for Medication (TSQM)

  1 day (the day of the encounter visit)

• Number of Adherence Days on the Self-reported Adherence Questionnaire

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

• Experience of Low Blood Sugar (Hypoglycemia) Questionnaire

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

• Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II

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

Study Arms (1)

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.

Other: Other: Retrospective chart review; one participant encounter visit.

Interventions

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.

All Enrolled Participants

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Merck Sharp & Dohme (I.A.) Corp.

Taipei, 106, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 27, 2011
• Study Start: January 10, 2011
• Primary Completion: December 27, 2012
• Study Completion: December 27, 2012
• Last Updated: May 21, 2024
• Results First Posted: March 24, 2014

Record last verified: 2024-04

Locations

TW (1)