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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04409795
Other study ID # 2019-76
Secondary ID
Status Enrolling by invitation
Phase Phase 2/Phase 3
First received
Last updated
Start date August 26, 2021
Est. completion date December 2024

Study information

Verified date March 2024
Source Joslin Diabetes Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 21
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metformin Extended Release Oral Tablet
Initial oral hypoglycemic agent added to existing insulin treatment
Sitagliptin
Secondary oral hypoglycemic agent added to existing insulin treatment (for those who are intolerant to or unable to achieve glycemic targets with metformin)

Locations

Country Name City State
United States Joslin Diabetes Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Joslin Diabetes Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycated hemoglobin (HbA1c) Change in HbA1c (%) between the two study groups 3 months and 6 months
Secondary Daily insulin dose Change in daily insulin dose (units/kg body weight) between the two study groups 3 months and 6 months
Secondary Body mass index (BMI) Change in BMI between the two study groups. Weight and height will be combined to report BMI in kg/m^2. 3 months and 6 months
Secondary C-peptide Change in C-peptide (ng/mL) between the two study groups 3 months and 6 months
Secondary Total cholesterol Change in total cholesterol (mg/dL) between the two study groups 3 months and 6 months
Secondary Low density lipoprotein (LDL)-cholesterol Change in LDL-cholesterol (mg/dL) between the two study groups 3 months and 6 months
Secondary High density lipoprotein (HDL)-cholesterol Change in HDL-cholesterol (mg/dL) between the two study groups 3 months and 6 months
Secondary Triglycerides Change in triglycerides (mg/dL) between the two study groups 3 months and 6 months
Secondary Area under the plasma concentration versus time curve (AUC) of C-peptide Change in AUC of C-peptide between the two study groups, as measured by the hyperglycemic/arginine clamp, at the end of the study 6 months
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