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NCT01683409 · ClinicalTrials.gov registry record · Phase 2

A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease

A Phase 2 study of Diabetic Kidney Disease, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 2
Development phase
130
Enrollment target
20
Study locations

NCT01683409: Completed Phase 2 study of Diabetic Kidney Disease, sponsored by Eli Lilly and Company.

NCT01683409 is a Phase 2 study of Diabetic Kidney Disease that has completed, run by Eli Lilly and Company. The registered enrollment target is 130 participants, below the 5,184-participant average among 23 other Diabetic Kidney Disease trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01683409, a Phase 2 study of Diabetic Kidney Disease, has completed, sponsored by Eli Lilly and Company.

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

Study Summary

This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the treatment of participants with mild to moderate diabetic kidney disease.

Primary Outcome

UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to \<50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.

Conditions Studied

Diabetic Kidney Disease

Interventions

  • DRUG Placebo
  • DRUG Baricitinib

Study Locations (20)

Florida

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Fort Lauderdale
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Jacksonville
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Miami
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Tampa

California

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Lancaster
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - San Diego
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Torrance

Michigan

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Ann Arbor
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Detroit
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Pontiac

Illinois

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Gurnee
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Peoria

Colorado

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Lakewood

Georgia

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Augusta

Hawaii

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Honolulu

Idaho

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Meridian

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2012-08
Est. Completion 2014-11
Phase Phase 2
Eli Lilly and Company

1,341 total trials

What the finished NCT01683409 record still lists

NCT01683409 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 5,184-participant average among 23 other Diabetic Kidney Disease trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Diabetic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01683409 names 20 study sites across 12 states, led by Florida, California, Michigan.

Frequently Asked Questions

What is clinical trial NCT01683409 about?

NCT01683409 is a clinical study titled "A Study to Test Safety and Efficacy of Baricitinib in Participants With Diabetic Kidney Disease". This is a dose ranging study to evaluate the safety and efficacy of baricitinib in the treatment of participants with mild to moderate diabetic kidney disease.

What is the current status of trial NCT01683409?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2012-08. Estimated completion is 2014-11.

What conditions does trial NCT01683409 study?

This clinical trial studies the following conditions: Diabetic Kidney Disease.

What interventions are being tested in trial NCT01683409?

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

Who is sponsoring clinical trial NCT01683409?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01683409 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Diabetic Kidney Disease

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 NCT01683409's enrollment target sits among peer trials

130 9th of 23 higher than 15 of 23 other Diabetic Kidney Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetic Kidney Disease 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

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Related registry views

Source: ClinicalTrials.gov NCT01683409, the US trial registry maintained by the National Library of Medicine. NCT01683409 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.