CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Glimepiride 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01614769
NCT01614769Phase 1Completed
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A Study to Assess the Effects of Glimepiride on Recovery From Hypoglycemia in Participants With Type 2 Diabetes Mellitus

Merck Sharp & Dohme LLC·interventional·Posted Jun 8, 2012·Updated Aug 16, 2018

In Brief

A Phase 1 clinical trial evaluating Placebo, Glimepiride 2 mg, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 10 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2012
Enrollment StartJul 18, 2012
Primary CompletionJan 9, 2013
Study CompletionJan 23, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.1 years ago

Interventions

Placebodrug

Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.

Glimepiride 2 mgdrug

One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.

Glimepiride 4 mgdrug

Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.

Hypoglycemic Clampprocedure

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.