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

NCT01278485 | Completed Results

• 1 other identifier: 0431-402
• Study Type: observational
• Target: 726
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes complications

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 6 Months Prior to Enrollment

• 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.

  Up to 6 Months Prior to Enrollment

• 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.

  Day of Enrollment

Secondary Outcomes (7)

• Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment

  Day of Enrollment

• Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment

  Day of Enrollment

• Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment

  Day of Enrollment

• Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment

  Day of Enrollment

• Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment

  Day of Enrollment

Study Arms (1)

Sulphonylurea (SU) Monotherapy or SU + Metformin

Participants with Type 2 diabetes that have been treated with SU monotherapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.

Drug: Sulphonylurea; Drug: Metformn

Interventions

Sulphonylurea DRUG

SU administered according to usual practice.

Sulphonylurea (SU) Monotherapy or SU + Metformin

Metformn DRUG

Metformin administered according to usual practice.

Sulphonylurea (SU) Monotherapy or SU + Metformin

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 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ merformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Complications

Interventions

Sulfonylurea Compounds

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 19, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 28, 2015
• Results First Posted: August 26, 2013

Record last verified: 2015-07