At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Comparison of PK/PD Dose Response Characteristics of Glargine in Type 2 Diabetics
In Brief
A Phase 1 clinical trial evaluating Placebo, Insulin Glargine 0.5 u/kg body wt SC, and 3 other interventions for Type 2 Diabetes. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The study is to determine the dose response relationship of insulin glargine in type 2 diabetes over a 24-hour period and measuring the differences in glucose production among the differing doses of glargine. Hypothesis: Differing doses of insulin glargine over a 24-hour period in type 2 diabetes will show differing effects on endogenous glucose production, glucose disposal and carbohydrate and lipid flux.
Study Details
Timeline
Interventions
single dose of Placebo injected s/c at 8am and monitor blood glucose over 24 hours
8 weeks later, a differing dose (0.5, 1.0, 1.5, 2.0 u/kg body wt.) of Insulin Glargine and monitoring over a 24 hour period each separated by 8 weeks (5 separate study visits)