CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Metformin +3 moredrug
Likely dose
Not stated in 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/NCT02597101
NCT02597101Phase 2Completed

Neutrophil Elastase Inhibition as Adjunctive Therapy to Improve Glucometabolic Variables in Overweight and Obese, Insulin-Resistant Type 2 Diabetic Patients

Nick Giannoukakis, PhD·interventional·Posted Nov 5, 2015·Updated May 13, 2021

In Brief

A Phase 2 clinical trial evaluating Metformin, saxagliptin, and 2 other interventions for Type 2 Diabetes Mellitus and Insulin Resistance. Completed, enrolled 14 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 5, 2015
Enrollment StartNov 1, 2015
Primary CompletionJun 10, 2019
Study CompletionJun 15, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.7 years ago

Interventions

Metformindrug

background drug

saxagliptindrug

background drug

AZD9668drug

study drug

placebodrug

placebo for AZD9668 to be added to background drugs