Brigham and Women's Hospital
A phase 2a trial randomized, double-blind, placebo-controlled, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily.
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: 1. 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 2. Has type 1 or type 2 diabetes mellitus, as indicated by any of the following: 1. Self-report of type 1 or type 2 diabetes plus the use of a prescribed medication. 2. ICD-10 code for type 1 or type 2 diabetes plus current use of a medication in the electronic medical record. 3. HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL 3. Has an average of two or more morning UACR equal to or above 100mg/g creatinine each of which must be equal…
The eligible participants will be assigned to receive either NMN or placebo using concealed block randomization in a 1:1 ratio, stratified by sex (male, female), age (60 to 75, \>75 years) and trial site. The randomization list will be generated by the unblinded biostatistician using the software R (www.r-project.org), and deployed in a secure, centralized web-based application accessible to study staff following confirmation of a participant's eligibility.
Placebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.
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