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Anti-Inflammatory Small Drug Adjunctive Therapy for Type 2 Diabetes

NCT02597101 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-05-13

Study results available
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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

Conditions

Interventions

DRUG

Metformin

background drug

DRUG

saxagliptin

background drug

DRUG

AZD9668

study drug

DRUG

placebo

placebo for AZD9668 to be added to background drugs

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Pittsburgh

    collaborator OTHER

  • University of South Florida

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Nick Giannoukakis, PhD

    lead OTHER

Principal Investigators

  • Nick Giannoukakis, Ph.D. · Allegheny Health Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2019-06-10
Completion
2019-06-15

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02597101 on ClinicalTrials.gov