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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):

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

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

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 
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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01614769     History of Changes
Other Study ID Numbers: 0000-253
First Submitted: June 6, 2012
First Posted: June 8, 2012
Results First Submitted: January 2, 2014
Results First Posted: February 24, 2014
Last Update Posted: April 27, 2017