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Completed

NCT Number: NCT04409795

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Monogenic Diabetes Nutritional and Metabolic Diseases

Age range

Up to 85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin Extended Release Oral Tablet

Drug

Initial oral hypoglycemic agent added to existing insulin treatment

Sitagliptin

Drug

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

Primary outcomes

  1. Glycated hemoglobin (HbA1c)

    Time frame: 3 months and 6 months

    Change in HbA1c (%) between the two study groups

Secondary outcomes

  1. Daily insulin dose

    Time frame: 3 months and 6 months

    Change in daily insulin dose (units/kg body weight) between the two study groups

  2. Body mass index (BMI)

    Time frame: 3 months and 6 months

    Change in BMI between the two study groups. Weight and height will be combined to report BMI in kg/m^2.

  3. C-peptide

    Time frame: 3 months and 6 months

    Change in C-peptide (ng/mL) between the two study groups

  4. Total cholesterol

    Time frame: 3 months and 6 months

    Change in total cholesterol (mg/dL) between the two study groups

  5. Low density lipoprotein (LDL)-cholesterol

    Time frame: 3 months and 6 months

    Change in LDL-cholesterol (mg/dL) between the two study groups

  6. High density lipoprotein (HDL)-cholesterol

    Time frame: 3 months and 6 months

    Change in HDL-cholesterol (mg/dL) between the two study groups

  7. Triglycerides

    Time frame: 3 months and 6 months

    Change in triglycerides (mg/dL) between the two study groups

  8. Area under the plasma concentration versus time curve (AUC) of C-peptide

    Time frame: 6 months

    Change in AUC of C-peptide between the two study groups, as measured by the hyperglycemic/arginine clamp, at the end of the study

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 1, 2020
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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