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

Lilly

Status and phase: Completed; Phase 2

Conditions: Diabetic Kidney Disease

Treatments: Drug: Baricitinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01683409

14734

I4V-MC-JAGQ (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 m²) (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

130 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Administered orally, given as three placebo tablets in the morning and one placebo tablet in the evening for 24 weeks.

Treatment:

Drug: Placebo

Baricitinib 0.75 mg/0.5 mg QD

Experimental group

Description:

Administered orally, 0.75 mg given as one 0.75 mg tablets and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

Treatment:

Drug: Placebo

Drug: Baricitinib

Baricitinib 0.75 mg/0.5 mg BID

Experimental group

Description:

Administered orally, 0.75 mg given as one 0.75 tablet and 2 placebo in the morning and one 0.75 mg tablet in the evening for 24 weeks or 0.5 mg given as one 0.5 mg tablet and two placebo tablets in the morning and one 0.5 mg tablet in the evening. Placebo tablets given to maintain blind.

Treatment:

Drug: Placebo

Drug: Baricitinib

Baricitinib 1.5 mg/1 mg

Experimental group

Description:

Administered orally, 1.5 mg given as two 0.75 mg tablets and 1 placebo tablet in the morning and one placebo tablet in the evening for 24 weeks or 1 mg tablet and two placebo tablets in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

Treatment:

Drug: Placebo

Drug: Baricitinib

Baricitinib 4 mg/2.75 mg

Experimental group

Description:

Administered orally, 4 mg given as one tablet and 2 placebo tablets in the morning and one placebo tablet in the evening for 24 weeks or 2.75 mg given as two 1 mg tablets and one 0.75 mg tablet in the morning and one placebo tablet in the evening for 24 weeks. Placebo tablets given to maintain blind.

Treatment:

Drug: Placebo

Drug: Baricitinib