NAD Augmentation in Diabetes Kidney Disease

This will be two centers, randomized, double-blind, placebo-controlled, parallel group trial to determine whether βNMN, after its daily oral administration, is associated with a greater reduction in the UACR compared to placebo.

The trial will enroll community-dwelling older adults, 60 years or older, with type 2 diabetes mellitus (T2DM) and urine albumin to creatinine excretion ratio > 100 mg/ g creatinine.

Inclusion criteria

• A man or a postmenopausal woman (complete cessation of menses for one or more years and /or FSH > 20 U/L), 30 years or older
• Has type 1 or type 2 diabetes mellitus, as indicated by any of the following:

• Self-report of type 1 or type 2 diabetes plus the use of a prescribed medication.
• ICD-10 code for type 1 or type 2 diabetes plus current use of a medication in the electronic medical record.
• HbA1c >6.4%; or 2 fasting glucose > 125 mg/dL
• Has an average of two or more morning UACR equal to or above 100mg/g creatinine each of which must be equal to or greater than 60 mg / g creatinine with at least one UACR value measured during the screening visit.

a. Recent UACR value in the medical record within the preceding 3 months prior to screening is acceptable.

• If type 2 diabetic and UACR is > 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB or a SGLT2 inhibitor.
• eGFR > 25 mL/ min / 1.73 m2
• Hemoglobin A1c <10%
• Able to speak English or Spanish or Haitian Creole
• Willing and able to provide written informed consent
• In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months.

Exclusion criteria

• Fasting morning UACR > 5,000 mg/ g creatinine
• Other laboratory abnormalities:

• Has AST or ALT > 3 times the upper limit of normal
• eGFR < 25 mL/ min / 1.73 m2
• Hematocrit < 0.34 or > 0.50 L/L
• A major adverse cardiovascular event in preceding 3 months
• Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter
• Current alcohol or substance use disorder or dependence (DSM 5 criteria).
• Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.
• An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month.
• Has a history of anaphylaxis from vitamin B3 derivatives
• BMI > 42.5 kg/ m2
• If patient has a confirmed diagnosis of type 3 diabetes, or gestational diabetes.