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Clinical Trial Details

Trial ID: L3639
Source ID: NCT01614769
Associated Drug: Placebo
Title: Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus (MK-0000-253)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01614769/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Placebo|DRUG: Glimepiride 2 mg|DRUG: Glimepiride 4 mg|PROCEDURE: Hypoglycemic Clamp
Outcome Measures: Primary: Recovery Time From Hypoglycemia to Euglycemia, Immediately after release of the hypoglycemic clamp, which maintained blood glucose close to 50 mg/dL, the time taken until glucose reached euglycemia, defined as 3 consecutive measurements \>= 70 mg/dL, is called the recovery time., From 1 to 180 minutes post hypoglycemic clamp|Rate of Recovery From Hypoglycemia to Euglycemia, The rate of recovery is the difference in concentration between blood glucose at euglycemia and at the end of the hypoglycemic clamp, divided by the recovery time., From 1 to 180 minutes post hypoglycemic clamp|Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery, The incremental weighted average qualitatively assesses overall hypoglycemic recovery by measuring mean glycemia over the 3 hour recovery period. Blood glucose measured at the release of the hypoglycemic clamp, considered the baseline value, was subtracted from blood glucose values measured over the ensuing 3 hours of hypoglycemic recovery. These differences from baseline were averaged to calculate the incremental weighted average blood glucose concentration., From 1 to 180 minutes post hypoglycemic clamp |
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-07-18
Completion Date: 2013-01-23
Results First Posted: 2014-02-24
Last Update Posted: 2018-08-16
Locations:
URL: https://clinicaltrials.gov/show/NCT01614769