Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study

Joslin Diabetes Center3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Monogenic Diabetes

Interventions

Metformin Extended Release Oral TabletDRUG

Initial oral hypoglycemic agent added to existing insulin treatment

SitagliptinDRUG

Secondary oral hypoglycemic agent added to existing insulin treatment (for those who are intolerant to or unable to achieve glycemic targets with metformin)

Eligibility

Sex: ALLMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Joslin Diabetes Center

Boston, Massachusetts, United States