Clinical trial for Type2diabetes
Official title NAD Augmentation in Diabetes Kidney Disease
ClinicalTrials.gov ID: NCT05759468
What this study is testing
What is MIB 626?
This is an investigational oral medicine being studied to see if it helps reduce kidney damage in people with type 2 diabetes. is designed to provide the body with a form of NAD+ precursor, which is a molecule involved in cellular energy and repair processes.
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
- The study wants to see whether NMN can reduce the amount of protein in the urine, a sign of kidney damage, compared with a placebo.
- Who it's for
- It is looking for adults who have type 2 diabetes and diabetic kidney disease.
- What's involved
- Participants will take either NMN or a placebo pill twice a day and will have urine tests to measure protein levels.
- Time commitment
- The trial lasts about 12 weeks, with regular clinic visits for medication and urine testing.
- 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
- 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...
You likely can't join if
- Fasting morning UACR \> 5,000 mg/ g creatinine
- 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
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
- 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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.