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

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ClinicalTrials.gov Identifier: NCT01614769
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : February 24, 2014
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

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
All Participants All randomized participants

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[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

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

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