Combination therapy for managing multiple metabolic issues in Type 1 Diabetes

Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes

This study is testing a new combination treatment for adults with Type 1 Diabetes to see if it can improve their blood sugar control and overall quality of life.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of California, San Diego (Academic / other)
• Drugs / interventions: volagidemab
• Locations: 1 site (La Jolla, California)
• Trial ID: NCT05696366 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to evaluate the effects of a combination adjunctive therapy on various metabolic parameters in adults with Type 1 Diabetes. It employs a single-site, double-blind, placebo-controlled, crossover design involving up to 22 participants. The study will assess glycemic control, ketogenesis during insulinopenia, insulin resistance, and overall diabetes burden and quality of life through a series of tests and treatments over a 12-week period. Participants will receive either sotagliflozin with placebo or sotagliflozin with volagidemab, with a washout period in between treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a stable insulin regimen and currently using a Continuous Glucose Monitoring system.

Not a fit: Patients who are not diagnosed with Type 1 Diabetes or those with unstable insulin regimens may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve glycemic control and quality of life for patients with Type 1 Diabetes.

How similar studies have performed: Other studies have shown promise with similar adjunctive therapies in managing Type 1 Diabetes, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Men and women between the ages of 18 and 70 years old, inclusive, at the time of screening;
2. Females of non-childbearing potential must be ≥ 1 year post-menopausal or documented as being surgically sterile. Females of childbearing potential must agree to use two methods of contraception during the entire study and for an additional 3 months after the end of dosing with the investigational product;
3. Male subjects must be willing to use clinically acceptable method of contraception during the entire study and for an additional 6 months after the end of the treatment period;
4. Diagnosed with Type 1 diabetes based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
5. Treatment with a stable insulin regimen for at least 8 weeks before screening with continuous subcutaneous insulin infusion (CSII) via an insulin pump or hybrid closed loop system;
6. Currently using a Continuous Glucose Monitoring (CGM) system;
7. A1c \> 7% and ≤ 10%
8. eGFR ≥ 60 mL/min/1.73m²;
9. Able to provide written informed consent approved by an Institutional Review Board (IRB).

Exclusion Criteria:

1. History or evidence of clinically significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;
2. History of pancreatitis, medullary thyroid carcinoma or liver disease;
3. Clinically significant diagnosis of anemia (Hemoglobin \< 9 g/dl at screening);
4. Body Mass Index (BMI) \< 18.5 kg/m2 and/or weight \<50kg;
5. Body Mass Index (BMI) \> 35 kg/m2
6. Whole blood donation of 1 pint (500 mL) within 8 weeks prior to Screening. Donations of plasma, packed RBCs, platelets or quantities less than 500 mL are allowed at investigator discretion;
7. Current or recent (within 1 month of screening) use of diabetes medications other than insulin; (examples include GLP-1 RA, SGLT-2i, Pramlintide, Metformin);
8. Women who are pregnant or lactating/breastfeeding;
9. Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
10. Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent.

Where this trial is running

La Jolla, California

• UC San Diego Altman Clinical & Translational Research Institute — La Jolla, California, United States (Recruiting)

Study contacts

• Study coordinator: Schafer Boeder

Conditions Type 1 Diabetes