NAD Augmentation in Diabetes Kidney Disease (DKD)
Type2diabetes, Diabetic Kidney Disease
About this trial
This is an interventional treatment trial for Type2diabetes focused on measuring diabetes, type 2 diabetes, kidney disease
Eligibility Criteria
Inclusion Criteria: Has T2DM, as indicated by any of the following: Self-report of diabetes plus the use of a prescribed diabetes medication. ICD-10 code for diabetes plus current use of a diabetes medication in the electronic medical record. HbA1c >6.4%; or 2 fasting glucose > 125 mg/dL Fasting morning UACR between 100 and 2,000 mg/g creatinine on two separate days If UACR is > 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB eGFR > 30 mL/ min / 1.73 m2 Hemoglobin A1c <9% Able to speak English or Spanish 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 > 2,000 mg/ g creatinine Other laboratory abnormalities: Has AST or ALT > 3 times the upper limit of normal creatinine > 2.5 mg/dL 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 Hypoglycemia unawareness or other medical conditions which could jeopardize participant's safety. History of alcohol or substance use disorder or dependence (DSM 5 criteria) within the last 2 years. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures. BMI > 42.5 kg/ m2
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Investigational Product - MIB 626
Placebo
The MIB-626 will be a GMP-grade microcrystalline solid NMN mixed with inert excipients (including microcrystalline cellulose) and compressed into tablets at a dose strength of 500 mg per tablet, enabling administration of the 1,000 mg twice daily using two tablets taken twice daily.
Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.