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Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 8, 2012
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: January 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Placebo
Drug: Glimepiride 2 mg
Drug: Glimepiride 4 mg
Procedure: Hypoglycemic Clamp

  Participant Flow

  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
All Participants All randomized participants

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 49.3  (5.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      4  40.0% 
Male      6  60.0% 

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Recovery Time From Hypoglycemia to Euglycemia   [ Time Frame: From 1 to 180 minutes post hypoglycemic clamp ]

2.  Primary:   Rate of Recovery From Hypoglycemia to Euglycemia   [ Time Frame: From 1 to 180 minutes post hypoglycemic clamp ]

3.  Primary:   Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery   [ Time Frame: From 1 to 180 minutes post hypoglycemic clamp ]

  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