NAD Augmentation in Diabetes Kidney Disease (DKD)

Mass General Brigham

Status and phase: Enrolling; Phase 2

Conditions: Type2diabetes; Diabetic Kidney Disease

Treatments: Drug: Investigational Product - MIB 626; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05759468

2021P003702

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has T2DM, as indicated by any of the following:

   1. Self-report of diabetes plus the use of a prescribed diabetes medication.
   2. ICD-10 code for diabetes plus current use of a diabetes medication in the electronic medical record.
   3. HbA1c >6.4%; or 2 fasting glucose > 125 mg/dL

2. Fasting morning UACR between 100 and 2,000 mg/g creatinine on two separate days

3. If UACR is > 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB

4. eGFR > 30 mL/ min / 1.73 m2

5. Hemoglobin A1c <9%

6. Able to speak English or Spanish

7. Willing and able to provide written informed consent

8. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months

Exclusion criteria

1. Fasting morning UACR > 2,000 mg/ g creatinine

2. Other laboratory abnormalities:

   1. Has AST or ALT > 3 times the upper limit of normal
   2. creatinine > 2.5 mg/dL
   3. Hematocrit < 0.34 or 0.50 L/L

3. A major adverse cardiovascular event in preceding 3 months

4. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter

5. Hypoglycemia unawareness or other medical conditions which could jeopardize participant's safety.

6. History of alcohol or substance use disorder or dependence (DSM 5 criteria) within the last 2 years.

7. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.

8. BMI > 42.5 kg/ m2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

140 participants in 2 patient groups, including a placebo group

Investigational Product - MIB 626

Active Comparator group

Description:

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.

Treatment:

Drug: Investigational Product - MIB 626

Placebo

Placebo Comparator group

Description:

Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.

Treatment:

Drug: Placebo