Actively Recruiting
Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes
Led by University of California, San Diego · Updated on 2024-11-04
24
Participants Needed
1
Research Sites
172 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
L
Lexicon Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single site, double-blind, placebo-controlled, crossover trial to quantify the effects of combination adjunctive therapy on glycemic control, ketogenesis during insulinopenia, insulin resistance, and diabetes burden and quality of life.
CONDITIONS
Official Title
Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women between the ages of 18 and 70 years old, inclusive, at the time of screening
- Females of non-childbearing potential must be 65 1 year post-menopausal or surgically sterile
- Females of childbearing potential must agree to use two methods of contraception during the study and for 3 months after dosing ends
- Male subjects must agree to use an acceptable method of contraception during the study and for 6 months after treatment ends
- Diagnosed with Type 1 diabetes by clinical history or ADA criteria
- On stable insulin regimen via insulin pump or hybrid closed loop for at least 8 weeks before screening
- Currently using a Continuous Glucose Monitoring system
- A1c greater than 7% and less than or equal to 10%
- Estimated glomerular filtration rate (eGFR) 65 60 mL/min/1.73m8
- Able to provide written informed consent approved by an Institutional Review Board (IRB)
You will not qualify if you...
- History or presence of any significant disorder that may risk safety or interfere with study procedures
- History of pancreatitis, medullary thyroid carcinoma, or liver disease
- Diagnosis of anemia with hemoglobin less than 9 g/dl at screening
- Body Mass Index (BMI) less than 18.5 kg/m2 or weight less than 50 kg
- Body Mass Index (BMI) greater than 35 kg/m2
- Whole blood donation of 500 mL within 8 weeks before screening
- Use of diabetes medications other than insulin within 1 month before screening
- Women who are pregnant or breastfeeding
- Unable or unwilling to follow study procedures or non-compliant with visits
- Any other condition that could reduce data quality, cause safety concerns, or affect informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UC San Diego Altman Clinical & Translational Research Institute
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
S
Schafer Boeder
CONTACT
T
Todd May
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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