Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment

Launched by YALE UNIVERSITY · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a medication called GLP-1 analogue on young adults who have both type 1 diabetes and obesity. The goal is to see if this treatment can help improve heart and metabolic health in these individuals, as being overweight can increase their risk for heart problems. The trial is currently recruiting participants aged 18 to 30 years who have had type 1 diabetes for at least a year and meet certain weight criteria. To qualify, they must also have stable insulin dosing and blood sugar levels.

Participants in the trial will receive the GLP-1 analogue treatment and will be monitored throughout the study. They will be asked to follow specific procedures and take the medication as directed. It's important that participants are willing to use effective birth control during the study if they can become pregnant. Overall, this trial aims to understand how this treatment can help young adults manage their weight and reduce heart-related risks associated with diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-30 years with T1D whose BMI meets FDA approval criteria for anti-obesity pharmacotherapy (BMI ≥30 kg/m2 alone or BMI ≥27 kg/m2 with a weight-related comorbidity)
• • Clinical diagnosis of T1D
• • Diabetes duration diagnosed ≥ 12 months ago
• • HbA1c ≤10% at screening and within the past 90 days
• • Stable reported insulin dosing in the past 90 days (within 15%)
• • Stable reported BMI in the past 90 days (within 5%)
• • Ability to provide written informed consent before any trial-related activities
• • Use of real-time continuous glucose monitoring and planned continued use
• • Females and males of childbearing potential willing to use highly effective methods of contraception for at least 1 month prior to randomization and agreement to use such a method during study participation and for 2 months after the last dose of study medication administration: Combined estrogen-progestogen contraception including: oral, intravaginal, transdermal (patch), Progestogen-only contraception: oral, injectable or implantable, Placement of an intrauterine device or intrauterine system, Bilateral tubal occlusion (fallopian tubes are blocked), Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate), or Complete sexual abstinence from male-female sex)
• • Stated willingness to comply with all study procedures, medication regimen, and availability for the duration of the study
• • Participants cannot be randomized if any laboratory safety parameter at screening is outside the below extended laboratory ranges. For randomization, participants should have
• • 1. Creatinine \<1.0mg
• • 2. Triglycerides (\<400 mg/dl)
• • 3. ALT \<3.5 times the upper normal limit (UNL)
• Exclusion Criteria:
• • Use of adjunctive diabetes therapies or anti-obesity medications (including any GLP-1 agonist) currently or within the past 6 months.
• • Insulin dosing \<0.5 units/kg/day
• • Current psychiatric conditions impacting weight, including known eating disorders
• * Contraindications to study medications, including:
• • Personal history of pancreatitis, renal impairment, or known liver disease other than non-alcoholic hepatic steatosis
• • Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia Type 2
• • Known or suspected allergy to semaglutide, excipients, or related products.
• • Use of lipid lowering medications other than statins and omega-3 products
• • Previous randomization in this trial. Participants who enrolled but did not randomize can be re-screened. Potential reasons for enrolment without randomization include scheduling conflicts for the baseline studies, or for females, not yet meeting the highly effective methods of contraception criteria.
• • Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
• • Diabetic ketoacidosis in the past 6 months
• • Not meeting MRI safety criteria or claustrophobia preventing participation in the MRI
• • Anemia or known hematologic condition impacting HbA1c reading, or another medical condition that precludes participation.
• • Treatment with another investigational drug or other intervention within the past 1 month
• • Subjects with a PHQ-9 score \>15 or those found to have a lifetime history of suicide attempts, or suicidal ideation within the past 3 months on the C-SSRS
• • Corn allergy
• • Subjects with severe hypoglycemia requiring hospitalization in the past 3 months
• • Clinically significant gastroparesis