Overview

This trial is active, not recruiting.

Condition diabetic kidney disease
Treatments baricitinib, placebo
Phase phase 2
Target JAK
Sponsor Eli Lilly and Company
Collaborator Incyte Corporation
Start date August 2012
End date September 2014
Trial size 250 participants
Trial identifier NCT01683409, 14734, I4V-MC-JAGQ

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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.
baricitinib LY3009104
Administered orally
placebo
Administered orally
(Experimental)
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.
baricitinib LY3009104
Administered orally
placebo
Administered orally
(Experimental)
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.
baricitinib LY3009104
Administered orally
placebo
Administered orally
(Experimental)
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.
baricitinib LY3009104
Administered orally
placebo
Administered orally
(Placebo Comparator)
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.
placebo
Administered orally

Primary Outcomes

Measure
Change from Baseline in Urinary Albumin/Creatinine Ratio (UACR) at 24 Weeks
time frame: Baseline, 24 Weeks

Secondary Outcomes

Measure
Change from Baseline in Creatinine Clearance at 24 Weeks
time frame: Baseline, 24 Weeks
Change from Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) at 24 Weeks
time frame: Baseline, 24 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.