Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02597101 · ClinicalTrials.gov registry record · Phase 2
Anti-Inflammatory Small Drug Adjunctive Therapy for Type 2 Diabetes
A Phase 2 study of Type 2 Diabetes Mellitus and Insulin Resistance, sponsored by Nick Giannoukakis, PhD.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02597101: Completed Phase 2 study of Type 2 Diabetes Mellitus and Insulin Resistance, sponsored by Nick Giannoukakis, PhD.
NCT02597101 is a Phase 2 study of Type 2 Diabetes Mellitus and Insulin Resistance that has completed, run by Nick Giannoukakis, PhD. The registered enrollment target is 14 participants, below the 2,960-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02597101, a Phase 2 study of Type 2 Diabetes Mellitus and Insulin Resistance, has completed, sponsored by Nick Giannoukakis, PhD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
The primary outcome measure is the insulin sensitivity at 6 months from baseline, assessed by the hyperinsulinemic-euglycemic clamp method. This is calculated as the M/LBM. M/LBM = whole-body insulin sensitivity adjusted for lean body mass. M/LBM is calculated as the steady-state glucose disposal (in mL) per kilogram lean body mass divided by steady-state insulin concentrations (micro IU/mL).
Conditions Studied
Interventions
- DRUG placebo
- DRUG Metformin
- DRUG saxagliptin
- DRUG AZD9668
Study Locations (1)
Pennsylvania
- Allegheny Health Network - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-11 |
| Est. Completion | 2019-06-15 |
| Phase | Phase 2 |
What the finished NCT02597101 record still lists
NCT02597101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 2,960-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 4 interventions - of which placebo is the first listed.
NCT02597101 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02597101 about?
NCT02597101 is a clinical study titled "Anti-Inflammatory Small Drug Adjunctive Therapy for Type 2 Diabetes". 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 i...
What is the current status of trial NCT02597101?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2015-11. Estimated completion is 2019-06-15.
What conditions does trial NCT02597101 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Insulin Resistance.
What interventions are being tested in trial NCT02597101?
The interventions under investigation include: placebo (DRUG), Metformin (DRUG), saxagliptin (DRUG), AZD9668 (DRUG).
Who is sponsoring clinical trial NCT02597101?
This trial is sponsored by Nick Giannoukakis, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02597101 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02597101's enrollment target sits among peer trials
14 122nd of 130 higher than 8 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes
RECRUITING · Phase 2
-
Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease
RECRUITING · Phase 2
-
Regulation of Endogenous Glucose Production by Central KATP Channels
RECRUITING · Phase 2
-
Signaling Mechanisms and Vascular Function in Patients With Diabetes Mellitus
COMPLETED · Phase 2
-
The Effect of Bariatric Surgery on Metabolism, the Metabolome and Microbiome in Patients With Type 2 Diabetes
COMPLETED · Phase 2
-
A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02523092 · 14 participants · Phase 4
Use of CXCL9 as a Biomarker of Acthar Efficacy
- NCT04263285 · 14 participants · NA
Treatment of Depression Post-SCI
- NCT04743271 · 14 participants · NA
Food and Circadian Timing
- NCT05065671 · 14 participants · Phase 1
Microbiome Derived Metabolism and Pharmacokinetics
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia