Phase 2 Type 2 Diabetes Trial, Recruiting NCT05759468 Sponsor: Brigham and Women's Hospital Condition: Type 2 Diabetes
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Phase 2 Type 2 Diabetes Trial, Recruiting

NCT05759468
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a man or a woman who has gone through menopause (no periods for at least one year), and you are 30 years old or older
  • You have been diagnosed with type 1 or type 2 diabetes, confirmed by a doctor's diagnosis plus medication, medical records, or blood test results
  • Your urine tests show a significant amount of protein (specifically, your urine albumin-to-creatinine ratio averages 100 or above across two morning tests, with each test result at least 60, and at least one test done during the screening visit)
  • If you have type 2 diabetes and your urine protein levels are quite high (UACR above 300), you must already be taking a specific type of blood pressure or kidney-protecting medication (ACE inhibitor, ARB, or SGLT2 inhibitor)
  • Your kidneys are working at a functional level above a certain threshold (confirm with trial site)
  • Your blood sugar control level (HbA1c) is below 10%
  • You are able to speak English, Spanish, or Haitian Creole
  • You are willing and able to sign a consent form
  • If you are female, you are not currently pregnant and do not plan to become pregnant in the next 6 months

Who may not be able to join:

  • Your urine protein levels are extremely high (UACR above 5,000) (confirm with trial site)
  • You have certain abnormal blood test results, including liver enzyme levels that are too high, kidney function that is too low, or blood count outside an acceptable range (confirm with trial site)
  • You have had a serious heart event (such as a heart attack or stroke) in the past 3 months
  • You have taken part in another clinical drug trial within the past 3 months (or within a specific timeframe based on that trial's medication)
  • You currently have an alcohol or substance use disorder
  • You have a diagnosis of major depression, bipolar disorder, schizophrenia, or are currently experiencing psychotic symptoms or behavioral issues that could affect your participation
  • You have been hospitalised for an acute illness (including COVID-19) in the past 3 months, or have had any acute illness in the past month
  • You have previously had a severe allergic reaction (anaphylaxis) to vitamin B3 or related products
  • Your body mass index (BMI) is above 42.5 (confirm with trial site if unsure how to calculate this)
  • You have been diagnosed with type 3 diabetes or gestational diabetes

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Shalender Bhasin, MD, Brigham and Women's Hospital

Phone: 6175259150

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
13 April 2023
Est. completion
30 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The primary endpoint is the change from baseline in UACR over the 6-month intervention period.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov