Placebo
DrugTwo gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.
NCT Number: NCT01614769
This study aims to assess how glimepiride affects the recovery from hypoglycemia in participants with type 2 diabetes mellitus. The primary objective is to estimate the time taken by participants to recover from hypoglycemia to euglycemia after treatment with either 2 mg or 4 mg of glimepiride when compared to placebo.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.
One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.
Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.
On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion is combined with a variable-rate dextrose infusion to maintain plasma glucose concentrations at close to 50 mg/dL for 30 minutes.
Time frame: From 1 to 180 minutes post hypoglycemic clamp
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.
Time frame: From 1 to 180 minutes post hypoglycemic clamp
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.
Time frame: From 1 to 180 minutes post hypoglycemic clamp
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.
Merck Sharp & Dohme LLC
Industry
A Study to Assess the Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus
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