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New treatment option for Type2diabetes
Official title NAD Augmentation in Diabetes Kidney Disease
ClinicalTrials.gov ID: NCT05759468
What this study is testing
What is Investigational Product - MIB 626?
Investigational Product - MIB 626 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for type2diabetes.
Also referred to as NMN.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join if
- 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
You likely can't join if
- 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 \ 0.50 L/L
- A major adverse cardiovascular event in preceding 3 months
See the full eligibility 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...
- 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.
- 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 \ 0.50 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.