NCT01053936

Who might be able to join this trial:

• You have been diagnosed with type 2 diabetes, and that diagnosis was made when you were older than 30 years of age (if you were younger at diagnosis, a special blood test may be used to confirm the type of diabetes)
• You are at least 18 years old
• Your kidney function test results (called eGFR) fall within a specific moderate range — between 15 and 45 — based on two tests done during the screening period
• You have been taking a blood pressure medication called an ACE inhibitor or an ARB (or both) for at least 8 weeks before screening, at a stable dose, with no planned changes during the study
• You agree to use effective birth control throughout the entire study and for at least 2 months after your last dose of the study drug, unless you have documented proof that you cannot have children
• If you are a woman who could potentially become pregnant, you must have a negative pregnancy test at screening and again before your first dose of the study drug
• You are willing and able to follow all parts of the study plan
• You are willing and able to sign a written consent form agreeing to take part in the study

Who may not be able to join:

• You have type 1 (insulin-dependent or juvenile-onset) diabetes, or you have ever had a serious condition called diabetic ketoacidosis
• You have known kidney disease that is not caused by diabetes, a family history of inherited kidney disease, or you have previously had a kidney transplant
• A kidney biopsy or clinical evidence shows you have a kidney condition other than diabetes-related kidney scarring (nephrosclerosis)
• Your blood pressure cannot be controlled below 160 (top number) and 90 (bottom number), based on readings taken at two separate visits at least 4 days apart
• Your HbA1c blood sugar level (a measure of long-term blood sugar control) is above 10% at screening
• You have had certain heart or cardiovascular problems recently or currently, including:
  • Unstable chest pain (unstable angina) in the past 3 months
  • A heart attack, heart bypass surgery, or coronary stent procedure in the past 3 months
  • A mini-stroke (transient ischemic attack) in the past 3 months
  • A stroke in the past 3 months
  • A serious heart valve problem or a thickened heart muscle condition
  • A significant heart rhythm block not successfully managed with a pacemaker
  • Severe (Class III or IV) heart failure
• Your heart rhythm test (ECG) shows a specific electrical measurement (QTc interval) above 450 milliseconds
• You have needed long-term immune-suppressing medications (including certain steroids, but not inhaled, nasal, or joint-injection steroids) within the past 3 months
• You regularly use anti-inflammatory painkillers (such as ibuprofen or naproxen) more than once or twice a week
• Your doses of blood pressure or diabetes medications have been changed within the past 6–8 weeks
• You are unwilling or unable to stop taking certain specific medications during the study — these include some cholesterol, liver, and other drugs sold under brand names such as Niaspan, Tricor, Lopid, Tasmar, Felbatol, and others (confirm with trial site for the full list); note that standard multivitamins with low amounts of niacin may still be allowed
• Your liver function blood tests show abnormal results at screening
• You have a history of hepatitis B or C (your eligibility would need to be discussed with the trial team individually; resolved hepatitis A with normal liver tests may still be eligible)
• You are currently pregnant, breastfeeding, or planning to become pregnant
• You have a known allergy or sensitivity to any ingredient in the study drug
• You have had a medical procedure using a contrast dye (such as a CT scan with dye) within the past 30 days
• You currently have a drug or alcohol problem, as assessed by the study doctor
• You have had cancer (other than certain minor skin cancers) within the past 5 years
• You have been on dialysis within the past 3 months, or your kidney function has not been stable over the past 3 months
• You have any other medical condition that the study doctor believes could put you at risk or affect the study