drugset / Trial / NCT02597101

Anti-Inflammatory Small Drug Adjunctive Therapy for Type 2 Diabetes

NCT02597101

RandomizedCrossoverQuadruple-blindTreatment

Summary

The role of individual leukocyte populations in type 2 diabetes (T2D) and immunometabolism in general represent important gaps in knowledge to better understand the etiopathogenesis of T2D. Emerging evidence indicates that certain leukocyte populations serve as an important nexus of T2D-associated inflammation. This novel and innovative clinical trial will test the efficacy of a leukocyte-selective anti-inflammatory small drug as adjunctive therapy in improving insulin sensitivity in obese, insulin-resistant type 2 diabetic subjects. This trial also offers a first-in-kind opportunity to better understand the role of specific leukocyte populations in type 2 diabetes. The drug's clinical profile suggests that it will be well-tolerated with few, if any, side effects, and the existence of simple methods that can indirectly measure its activity in vivo

Timeline

Start
2015-11
Primary completion
2019-06-10
Completion
2019-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Alvelestat Small molecule 60 mg Oral
Background Metformin Small molecule 500 mg
Background Metformin Small molecule 2000 mg
Background SAXAGLIPTIN ANHYDROUS Small molecule 5 mg