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COMPLETED Phase 2

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

NCT02010242 · View on ClinicalTrials.gov ↗

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

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02010242

The ClinicalTrials.gov registry entry for NCT02010242 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02010242 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Texas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02010242?

The interventions under investigation include: Placebo (DRUG), GKT137831 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02010242?

This trial is sponsored by Calliditas Therapeutics AB, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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