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

This study is currently recruiting participants.
Verified May 2013 by Eli Lilly and Company
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01683409
First received: September 7, 2012
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Kidney Disease
 Drug: baricitinib
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2 Study to Evaluate the Safety and Renal Efficacy of LY3009104 in Patients With Diabetic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline in Urinary Albumin/Creatinine Ratio (UACR) at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Creatinine Clearance at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose baricitinib (once daily)

Dose Group 1

Administered orally, given as three tablets in the morning and one tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

 Drug: baricitinib
Administered orally
Other Names:
  • LY3009104
  • INCB28050
Drug: Placebo
Administered orally
Experimental: Medium dose baricitinib (once daily)

Dose Group 2

Administered orally, given as three tablets in the morning and one tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

 Drug: baricitinib
Administered orally
Other Names:
  • LY3009104
  • INCB28050
Drug: Placebo
Administered orally
Experimental: Medium dose baricitinib (twice daily)

Dose Group 3

Administered orally, given as three tablets in the morning and one tablet in the evening for 24 weeks. The total daily dose remains the same as Dose Group 2. Placebo tablets given to maintain blind.

 Drug: baricitinib
Administered orally
Other Names:
  • LY3009104
  • INCB28050
Drug: Placebo
Administered orally
Experimental: Low dose baricitinib (once daily)

Dose Group 4

Administered orally, given as three tablets in the morning and one tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

 Drug: baricitinib
Administered orally
Other Names:
  • LY3009104
  • INCB28050
Drug: Placebo
Administered orally
Placebo Comparator: Placebo
Placebo administered orally, twice daily, three tablets in the morning and one tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.
 Drug: Placebo
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with Type 2 diabetes treated with at least one antihyperglycemic medicine for 12 months
  • Have diabetic kidney disease and receiving one of two specific medicines used to treat high blood pressure or diabetic kidney disease for at least 3 months
  • Estimated Glomerular Filtration Rate (eGFR) of 25 to 70 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) (as determined by the Chronic Kidney Disease Epidemiology Collaboration equation) and a urinary albumin/creatinine ratio (UACR) >300 milligram per gram (mg/g) and <5000 mg/g

Exclusion Criteria:

  • Too high blood pressure when you enter the study
  • Some specific medicines used to treat high blood pressure or diabetic kidney disease
  • Frequent high blood glucose levels
  • Renal transplant or past history of dialysis
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Had a special X-ray in the past 30 days which involved also receiving an injection of dye into the vein
  • Major surgery within 8 weeks of study entry or will require major surgery during the study
  • Some types of vaccination
  • Shingles or currently have symptoms of a cold sore
  • Serious viral, bacterial, fungal, or parasitic infection, or a urinary infection, Tuberculosis (TB)
  • Human immunodeficiency virus (HIV) infection- the virus that causes Acquired immunodeficiency syndrome (AIDS)
  • Have or had some blood disorders, enlarged lymph glands or spleen, or some cancers.
  • Serious circulatory, breathing, liver, stomach or bowel problems, neurological or psychiatric disorders
  • Heart attack or heart failure, or a stroke
  • Other serious disorders or illnesses
  • Electrocardiogram (ECG) heart trace abnormalities
  • Alcohol or illegal drug abuse
  • Donated more than 500 mL of blood in the last 30 days (no blood donations allowed during the study)
  • Pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683409

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or : 1-317-615-4559

  Show 49 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Incyte Corporation
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01683409     History of Changes
Other Study ID Numbers: 14734, I4V-MC-JAGQ
Study First Received: September 7, 2012
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Federal Commission for Protection Against Health Risks

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 13, 2013