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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01278485
First received: January 13, 2011
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: May 14, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Sulphonylurea
Drug: Metformn

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven participants who failed to meet all the inclusion criteria were excluded from the study.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Adults With Type 2 Diabetes Mellitus ≥30 Years of Age  
STARTED     719  
COMPLETED     719  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

Baseline Measures
    Adults With Type 2 Diabetes Mellitus ≥30 Years of Age  
Number of Participants  
[units: participants]
  719  
Age  
[units: years]
Mean ± Standard Deviation
  65.91  ± 9.98  
Gender  
[units: participants]
 
Female     319  
Male     400  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment   [ Time Frame: Up to 6 Months Prior to Enrollment ]

2.  Primary:   Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment   [ Time Frame: Up to 6 Months Prior to Enrollment ]

3.  Primary:   Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment   [ Time Frame: Day of Enrollment ]

4.  Secondary:   Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment   [ Time Frame: Day of Enrollment ]

5.  Secondary:   Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment   [ Time Frame: Day of Enrollment ]

6.  Secondary:   Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment   [ Time Frame: Day of Enrollment ]

7.  Secondary:   Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment   [ Time Frame: Day of Enrollment ]

8.  Secondary:   Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment   [ Time Frame: Day of Enrollment ]

9.  Secondary:   Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment   [ Time Frame: Up to 12 Months Prior to Enrollment ]

10.  Secondary:   Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment   [ Time Frame: Up to 12 Months Prior to Enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01278485     History of Changes
Other Study ID Numbers: 0431-402
Study First Received: January 13, 2011
Results First Received: May 14, 2013
Last Updated: August 5, 2014
Health Authority: Korea: Institutional Review Board