Phase
Condition
Obesity
Diabetes Mellitus Types I And Ii
Diabetes Mellitus, Type 1
Treatment
Semaglutide
Placebo
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For an eligible subject, all inclusion criteria must be answered "yes"
Age ≥18 and ≤ 65 years
Patients with clinical diagnosis of T1D diagnosed for at least 12 months
Patient is on FDA- approved hybrid closed-loop system for ≥ 3 months
Willing to use once weekly semaglutide
Willing to share devices (HCL system) data uploads
HbA1c >7.0% and <10.0%
Body mass index ≥30 kg/m2
Has current glucagon product to treat severe hypoglycemia
Has current ketone meters to check ketones
Ability to provide informed consent before any trial-related activities
Exclusion
Exclusion Criteria:
Age <18 years and >65 years
HbA1c ≤7.0 % or ≥ 10.0% at screening
Less than 12 months of insulin treatment
Use of unapproved insulin for HCL system. E.g. use of Fiasp in the Tandem Control-IQsystem
Not willing to share the devices (HCL system) data uploads
Non compatible devices (e.g. pump, CGM or smart phones) for data transfer
Current use of multiple daily injection or inhaled insulin (Afrezza)
Patients with T1D using any glucose lowering medications other than insulin at thetime of screening
Pregnancy, breast feeding, and positive pregnancy test during screening
Women of childbearing age wanting to become pregnant
Unwilling to use acceptable contraceptive methods (for both men and women) duringthe trial period
Current use (≥ 2 weeks of continuous use) of any steroidal medication, oranticipated long-term steroidal treatment (>4 weeks continuously), during the studyperiod
Use of GLP-1RA or weight loss medications in the past 3 month
Clinical diagnosis/history of gastroparesis or gastric motility disorders
Serum triglycerides >500 mg/dL
Planning for bariatric surgery during the study period
eGFR below 45 ml/min/1.73 m^2 using CKD-EPI formula
History of severe hypoglycemia in the previous 3 months
History of diabetic ketoacidosis requiring hospitalization in the past 3 months
History of allergy to any form of insulin, GLP-1RA or its excipients
History of any form of pancreatitis
History of stroke, myocardial infarction in the past 3 months
History of congestive heart failure class III or IV
History of acute or chronic liver disease
History of malignancy requiring chemotherapy, surgery or radiation in previous 5years
Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) orfamilial thyroid carcinoma or non-familial medullary thyroid carcinoma
Have a pacemaker, metal implants, or aneurysm clips or weigh >330 lbs (exclusiononly if doing MRI)
Use of investigational drugs within 5 half-lives prior to screening
Participation to other intervention trials during the study period
Any comorbidities or medical conditions such as severe psychiatric disorder thatmake a person unfit for the study at the discretion of the investigators
Study Design
Study Description
Connect with a study center
Barbara Davis Center for Diabetes
Aurora, Colorado 80045
United StatesSite Not Available
Iowa Diabetes Research Center
West Des Moines, Iowa 50265
United StatesSite Not Available
Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
Harold Schnitzer Diabetes Health Center
Portland, Oregon 97239
United StatesSite Not Available
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