Phase
Condition
Diabetes And Hypertension
Diabetes Mellitus, Type 2
Diabetes Mellitus Types I And Ii
Treatment
Placebo
Semaglutide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ability to provide informed consent before any trial-related activities.Trial-related activities are any procedures that are carried out as a part of trial,including activities to determine suitability for the trial.
Male or female Adults (age > 18 years at the time of signing the consent)
Type 2 diabetes mellitus diagnosed > 6 months prior to screening
On current chronic treatment with Hemodialysis or Peritoneal dialysis for > 6 monthsprior to screening
Current treatment with any glucose lowering pharmacotherapy, at a stable dose for atleast 30 days. DPP-4 Inhibitors will be allowed at study entry and will be stoppedat randomization.
Minimum of 80% valid data on the 10-day Continuous Glucose Monitor download
Time in Range 15 to 60%
Exclusion
Exclusion Criteria:
BMI < 23 kg/m2 at screening
Current (within the past 90 days of screening) use of any GLP-1 RA
Personal or family history of medullary thyroid cancer or Multiple EndocrineNeoplasia type 2
Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, orrelated products)
Pregnant, breast-feeding or the intention of becoming pregnant, or not usingeffective contraceptive measures
Active weight loss, defined as weight loss of >5% of body weight in the past 3months
Current participation in other interventional trials or last dose of anyinvestigational product within 4 half- lives at the time of randomization
Any medical condition which in the judgement of the investigator precludes safeparticipation in the trial (includes, but not limited to active neoplasm, severeheart failure, recent cardiovascular event, severe frailty, planned cardiac orvascular surgeries on the day of screening etc)
If weight loss is not desired by the participant, or if the provider or investigatorconsiders intentional weight loss to be detrimental to the health of the participant
Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetesmellitus, MODY, LADA, drug induced, etc.)
Current diagnosis of gastroparesis or enteropathywhich in the opinion ofinvestigator precludes safe treatment with GLP-1 RA.
Hypoglycaemia unawareness, or history of frequent or severe hypoglycaemia (in theopinion of the investigator)
Personal history of chronic pancreatitis, or acute pancreatitis within 180 days ofscreening
Known current uncontrolled or unstable retinopathy (by medical history)
Study Design
Study Description
Connect with a study center
University of North Carolina
Chapel Hill, North Carolina 27599
United StatesSite Not Available
University of North Carolina
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
DaVita UT Southwestern - East Dallas
Dallas, Texas 75228
United StatesActive - Recruiting
DaVita UT Southwestern - Preston
Dallas, Texas 75240
United StatesSite Not Available
Davita UT Southwestern - Oak Cliff
Dallas, Texas 75224
United StatesActive - Recruiting
DaVita UT Southwestern - Irving
Irving, Texas 75062
United StatesSite Not Available
DaVita UT Southwestern - East Dallas
Dallas 4684888, Texas 4736286 75228
United StatesSite Not Available
DaVita UT Southwestern - Preston
Dallas 4684888, Texas 4736286 75240
United StatesSite Not Available
Davita UT Southwestern - Oak Cliff
Dallas 4684888, Texas 4736286 75224
United StatesSite Not Available
DaVita UT Southwestern - Irving
Irving 4700168, Texas 4736286 75062
United StatesSite Not Available

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