A Pilot Trial of Adding Oral Hypoglycemic Therapy to Insulin Treatment in Monogenic Variant Carriers of the Joslin 50-Year Medalist Study

2019-76

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.

2021-08-26

2024-12-01

2024-12-01

Early phase I

21

Inclusion Criteria: * 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 Exclusion Criteria: * 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 liver disease or liver function tests (AST or ALT)\>3x the upper limit of normal * Pre-existing kidney disease (Chronic Kidney Disease Stage IV and below, or estimated glomerular filtration rate\<45 mL/min/1.73 m2) * Active use of immunosuppressants * Recipients of prior islet cell or pancreas transplantation * Inability to travel due to frailty or health reasons * Donated blood within the previous two (2) months

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 21, 'type': 'ESTIMATED'}}

2024-03-08