NCT04409795CompletedPhase 2/3
Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study
A Pilot Trial of Adding Oral Hypoglycemic Therapy to Insulin Treatment in Monogenic Variant Carriers of the Joslin 50-Year Medalist Study
Source: ClinicalTrials.gov · Last updated 24 Feb 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy of adding oral hypoglycemic agents (OHA) to existing insulin treatment in monogenic variant carriers of the Joslin 50-Year Medalist Study ("Medalists"), who are characterized by ≥50 years of insulin-dependent diabetes. Our primary objective is to evaluate whether the presence of human leukocyte antigen (HLA) high-risk alleles for diabetes (DR3 and/or DR4) can affect the effectiveness of OHA in these subjects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 14 Nov 2019
- Start date
- 26 Aug 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Joslin Diabetes Center
- Diseases
- Type 1 diabetes
- NCT number
- NCT04409795
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 3
- From 26 Aug 2021 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recipients of prior islet cell or pancreas transplantation
- Donated blood within the previous two (2) months
Other illness
- Known diagnosis of cancer or active inflammatory disease such as rheumatoid arthritis, lupus, and inflammatory bowel disease
- Recent history of myocardial infarction, angioplasty, bypass surgery, heart failure, angina, stroke, or uncontrolled hypertension\>160/100 during the past 3 months
- Known diagnosis of cognitive dysfunction, dementia or Alzheimer's disease
- Pre-existing kidney disease (Chronic Kidney Disease Stage IV and below, or estimated glomerular filtration rate\<45 mL/min/1.73 m2)
Lab values
- Pre-existing liver disease or liver function tests (AST or ALT)\>3x the upper limit of normal
Other
- Active use of immunosuppressants
- Inability to travel due to frailty or health reasons
Who the study is looking for
- Existing participants in the Joslin 50-Year Medalist Study
- Residing in the United States
- Capable of giving informed consent
- Known detectable C-peptide \>0.05 ng/mL
Age in the registry: - to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Joslin Diabetes Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.