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NCT02010242 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria

A Phase 2 study of Type 2 Diabetes Mellitus With Diabetic Nephropathy, sponsored by Calliditas Therapeutics AB.

Completed
Registry status
Phase 2
Development phase
136
Enrollment target
20
Study locations

NCT02010242 is a Phase 2 study of Type 2 Diabetes Mellitus With Diabetic Nephropathy that has completed, run by Calliditas Therapeutics AB. The registered enrollment target is 136 participants. The trial reports 20 study locations across 12 states.

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The verdict

NCT02010242, a Phase 2 study of Type 2 Diabetes Mellitus With Diabetic Nephropathy, has completed, sponsored by Calliditas Therapeutics AB.

COMPLETED
Registry status
Phase 2
Development phase
136 participants
Enrollment target
20
Study locations

Study Summary

NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4 inhibitor. The primary objective of this study is to evaluate the efficacy of oral GKT137831 in patients with residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone system.

Interventions

  • DRUG Placebo
  • DRUG GKT137831

Study Locations (20)

Florida

  • Clinical Research of South Florida - Coral Gables
  • The Center for Diabetes and Endocrine Care - Hollywood
  • Jacksonville Center for Clinical Research - Jacksonville
  • Genoma Research Group, Inc. - Miami
  • Coral Research Clinic - Miami
  • Pines Clinical Research Inc. - Pembroke Pines
  • Volunteer Medical Research - Port Charlotte

Texas

  • The University of Texas Southwestern Medical Center - Dallas
  • 17070 Red Oak dr Ste 103 - Houston
  • Dialysis West University Health System - San Antonio

Arizona

  • Advanced Arizona Clinical Research - Tucson

California

  • The Endocrine Medical Group, Inc - Orange

Illinois

  • John H. Stroger Jr. Hospital of Cook County - Chicago

Indiana

  • Community Medical Research Partners - Indianapolis

Missouri

  • Kansas City VA Medical Center - Kansas City

Nebraska

  • Creighton Diabetes Center - Omaha

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2013-10
Est. Completion 2015-03
Phase Phase 2

Sponsor

Calliditas Therapeutics AB

5 total trials

What the Registry Record Tells You About NCT02010242

The ClinicalTrials.gov registry entry for NCT02010242 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calliditas Therapeutics AB, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 2 Diabetes Mellitus With Diabetic Nephropathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02010242 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, Texas, Arizona.

Frequently Asked Questions

What is clinical trial NCT02010242 about?

NCT02010242 is a clinical study titled "Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria". NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4 inhibitor. The primary objective of this study is to evaluate the efficacy of oral GKT137831 in patients with residual albumin...

What is the current status of trial NCT02010242?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2013-10. Estimated completion is 2015-03.

What conditions does trial NCT02010242 study?

This clinical trial studies the following conditions: Type 2 Diabetes Mellitus With Diabetic Nephropathy.

What interventions are being tested in trial NCT02010242?

The interventions under investigation include: Placebo (DRUG), GKT137831 (DRUG).

Who is sponsoring clinical trial NCT02010242?

This trial is sponsored by Calliditas Therapeutics AB, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02010242 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.