Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 10
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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. arm 3: 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. arm 4: 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. arm 5: 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. arm 6: 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.

Interventions: intervention 1: Placebo intervention 2: Glimepiride 2 mg intervention 3: Glimepiride 4 mg intervention 4: Hypoglycemic Clamp
Intervention descriptions: intervention 1: Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods. intervention 2: One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods. intervention 3: Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods. intervention 4: 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.

Protocol document: