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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.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01614769
First received: June 6, 2012
Last updated: July 1, 2014
Last verified: July 2014
Results First Received: January 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, 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
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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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo → Glimepiride 2 mg → Glimepiride 4 mg Participants received placebo in the first period, 2 mg glimepiride in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
Glimepiride 2 mg → Glimepiride 4 mg → Placebo Participants received 2 mg glimepiride in the first period, 4 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
Glimepiride 4 mg → Placebo → Glimepiride 2 mg Participants received 4 mg glimepiride in the first period, placebo in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
Placebo → Glimepiride 4 mg → Glimepiride 2 mg Participants received placebo in the first period, 4 mg glimepiride in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
Glimepiride 2 mg → Placebo → Glimepiride 4 mg Participants received 2 mg glimepiride in the first period, placebo in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
Glimepiride 4 mg → Glimepiride 2 mg → Placebo Participants received 4 mg glimepiride in the first period, 2 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.

Participant Flow for 5 periods

Period 1:   Period 1
    Placebo → Glimepiride 2 mg → Glimepiride 4 mg     Glimepiride 2 mg → Glimepiride 4 mg → Placebo     Glimepiride 4 mg → Placebo → Glimepiride 2 mg     Placebo → Glimepiride 4 mg → Glimepiride 2 mg     Glimepiride 2 mg → Placebo → Glimepiride 4 mg     Glimepiride 4 mg → Glimepiride 2 mg → Placebo  
STARTED     2     1     2     2     1     2  
COMPLETED     1     1     2     0     1     1  
NOT COMPLETED     1     0     0     2     0     1  
Discontinued due to Hypoglycemia                 0                 0                 0                 1                 0                 1  
Protocol Violation                 0                 0                 0                 1                 0                 0  
Withdrawal by Subject                 1                 0                 0                 0                 0                 0  

Period 2:   7-Day Washout
    Placebo → Glimepiride 2 mg → Glimepiride 4 mg     Glimepiride 2 mg → Glimepiride 4 mg → Placebo     Glimepiride 4 mg → Placebo → Glimepiride 2 mg     Placebo → Glimepiride 4 mg → Glimepiride 2 mg     Glimepiride 2 mg → Placebo → Glimepiride 4 mg     Glimepiride 4 mg → Glimepiride 2 mg → Placebo  
STARTED     1     1     2     0     1     1  
COMPLETED     1     1     2     0     1     1  
NOT COMPLETED     0     0     0     0     0     0  

Period 3:   Period 2
    Placebo → Glimepiride 2 mg → Glimepiride 4 mg     Glimepiride 2 mg → Glimepiride 4 mg → Placebo     Glimepiride 4 mg → Placebo → Glimepiride 2 mg     Placebo → Glimepiride 4 mg → Glimepiride 2 mg     Glimepiride 2 mg → Placebo → Glimepiride 4 mg     Glimepiride 4 mg → Glimepiride 2 mg → Placebo  
STARTED     1     1     2     0     1     1  
COMPLETED     1     1     2     0     1     1  
NOT COMPLETED     0     0     0     0     0     0  

Period 4:   7-Day Washout
    Placebo → Glimepiride 2 mg → Glimepiride 4 mg     Glimepiride 2 mg → Glimepiride 4 mg → Placebo     Glimepiride 4 mg → Placebo → Glimepiride 2 mg     Placebo → Glimepiride 4 mg → Glimepiride 2 mg     Glimepiride 2 mg → Placebo → Glimepiride 4 mg     Glimepiride 4 mg → Glimepiride 2 mg → Placebo  
STARTED     1     1     2     0     1     1  
COMPLETED     1     1     2     0     1     1  
NOT COMPLETED     0     0     0     0     0     0  

Period 5:   Period 3
    Placebo → Glimepiride 2 mg → Glimepiride 4 mg     Glimepiride 2 mg → Glimepiride 4 mg → Placebo     Glimepiride 4 mg → Placebo → Glimepiride 2 mg     Placebo → Glimepiride 4 mg → Glimepiride 2 mg     Glimepiride 2 mg → Placebo → Glimepiride 4 mg     Glimepiride 4 mg → Glimepiride 2 mg → Placebo  
STARTED     1     1     2     0     1     1  
COMPLETED     1     1     1     0     1     1  
NOT COMPLETED     0     0     1     0     0     0  
Withdrawal by Subject                 0                 0                 1                 0                 0                 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.
No text entered.

Reporting Groups
  Description
All Participants All randomized participants

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  10  
Age  
[units: Years]
Mean ± Standard Deviation
  49.3  ± 5.5  
Gender  
[units: Participants]
 
Female     4  
Male     6  



  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
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Time Frame Up to 14 days after last dose of study drug
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Placebo Participants received placebo in a treatment period.
Glimepiride 2 mg Participants received 2 mg Glimepiride in a treatment period.
Glimepiride 4 mg Participants received 4 mg Glimepiride in a treatment period.

Other Adverse Events
    Placebo     Glimepiride 2 mg     Glimepiride 4 mg  
Total, other (not including serious) adverse events        
# participants affected / at risk     3/9     2/6     4/7  
Gastrointestinal disorders        
Abdominal pain upper † 1      
# participants affected / at risk     0/9 (0.00%)     1/6 (16.67%)     0/7 (0.00%)  
# events     0     1     0  
Constipation † 1      
# participants affected / at risk     1/9 (11.11%)     0/6 (0.00%)     0/7 (0.00%)  
# events     1     0     0  
Nausea † 1      
# participants affected / at risk     0/9 (0.00%)     2/6 (33.33%)     0/7 (0.00%)  
# events     0     2     0  
Vomiting † 1      
# participants affected / at risk     0/9 (0.00%)     1/6 (16.67%)     0/7 (0.00%)  
# events     0     1     0  
General disorders        
Asthenia † 1      
# participants affected / at risk     0/9 (0.00%)     0/6 (0.00%)     1/7 (14.29%)  
# events     0     0     1  
Oedema peripheral † 1      
# participants affected / at risk     1/9 (11.11%)     0/6 (0.00%)     0/7 (0.00%)  
# events     1     0     0  
Infections and infestations        
Nasopharyngitis † 1      
# participants affected / at risk     0/9 (0.00%)     0/6 (0.00%)     1/7 (14.29%)  
# events     0     0     1  
Investigations        
Body temperature increased † 1      
# participants affected / at risk     1/9 (11.11%)     0/6 (0.00%)     0/7 (0.00%)  
# events     1     0     0  
Metabolism and nutrition disorders        
Hypoglycaemia † 1      
# participants affected / at risk     1/9 (11.11%)     1/6 (16.67%)     1/7 (14.29%)  
# events     1     1     1  
Musculoskeletal and connective tissue disorders        
Arthralgia † 1      
# participants affected / at risk     1/9 (11.11%)     0/6 (0.00%)     0/7 (0.00%)  
# events     1     0     0  
Nervous system disorders        
Dizziness † 1      
# participants affected / at risk     1/9 (11.11%)     0/6 (0.00%)     0/7 (0.00%)  
# events     1     0     0  
Dizziness postural † 1      
# participants affected / at risk     1/9 (11.11%)     0/6 (0.00%)     0/7 (0.00%)  
# events     1     0     0  
Headache † 1      
# participants affected / at risk     2/9 (22.22%)     0/6 (0.00%)     1/7 (14.29%)  
# events     2     0     1  
Respiratory, thoracic and mediastinal disorders        
Sinus congestion † 1      
# participants affected / at risk     0/9 (0.00%)     0/6 (0.00%)     1/7 (14.29%)  
# events     0     0     1  
Skin and subcutaneous tissue disorders        
Hyperhidrosis † 1      
# participants affected / at risk     0/9 (0.00%)     0/6 (0.00%)     1/7 (14.29%)  
# events     0     0     1  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA Version 15.1



  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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