NCT06042153

Brief Summary

This study will look at control of blood sugar levels in persons with type 2 diabetes mellitus currently on chronic dialysis. Researchers will compare blood sugar levels in people taking semaglutide to people taking "dummy" medicine. The treatment participants get will be decided randomly. Participants will need to inject the study medication once a week. The study will last for 1 year and a month. Participants will be asked to wear a sensor that measures blood sugar levels for a period of 10 days at five different time points during the study.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes

Timeline
27mo left

Started Dec 2023

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Dec 2023Sep 2028

First Submitted

Initial submission to the registry

September 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 5, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

September 11, 2023

Last Update Submit

January 9, 2026

Conditions

Type 2 DiabetesEnd Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (1)

  • Change in TIR (70-180 mg/dl)

    Measured in percentage by Continuous glucose monitor (CGM)

    Baseline, 52 weeks

Secondary Outcomes (25)

  • Change in Time in high range (180-250 mg/dl)

    Baseline, 52 weeks

  • Change in Time in very high range (>250 mg/dl)

    Baseline, 52 weeks

  • Change in Time in low range (54-69 mg/dl)

    Baseline, 52 weeks

  • Change in Time in very low range (<54 mg/dl)

    Baseline, 52 weeks

  • Proportion of participants with TIR 70-180 mg/dl for 70% of the day

    52 weeks

  • +20 more secondary outcomes

Study Arms (2)

Arm 1 - Semaglutide

EXPERIMENTAL

Participants will receive semaglutide as an adjunct to standard-of-care.

Drug: Semaglutide

Arm 2- Placebo

PLACEBO COMPARATOR

Participants will receive placebo (semaglutide) as an adjunct to standard-of-care.

Drug: Placebo

Interventions

SemaglutideDRUG

Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.25 mg; dose will gradually be increased every 4 weeks up to 1.0 mg.

Arm 1 - Semaglutide
PlaceboDRUG

Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.

Arm 2- Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 months prior to screening
  • Current treatment with any glucose lowering pharmacotherapy, at a stable dose for at least 30 days. DPP-4 Inhibitors will be allowed at study entry and will be stopped at randomization.
  • Minimum of 80% valid data on the 10-day Continuous Glucose Monitor download
  • Time in Range 15 to 60%

You may not qualify if:

  • 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 Endocrine Neoplasia type 2
  • Known or suspected hypersensitivity to GLP-1 RA (trial medication(s), excipients, or related products)
  • Pregnant, breast-feeding or the intention of becoming pregnant, or not using effective contraceptive measures
  • Active weight loss, defined as weight loss of \>5% of body weight in the past 3 months
  • Current participation in other interventional trials or last dose of any investigational product within 4 half- lives at the time of randomization
  • Any medical condition which in the judgement of the investigator precludes safe participation in the trial (includes, but not limited to active neoplasm, severe heart failure, recent cardiovascular event, severe frailty, planned cardiac or vascular surgeries on the day of screening etc)
  • If weight loss is not desired by the participant, or if the provider or investigator considers intentional weight loss to be detrimental to the health of the participant
  • Other or secondary forms of diabetes (like type 1 diabetes, pancreatogenic diabetes mellitus, MODY, LADA, drug induced, etc.)
  • Current diagnosis of gastroparesis or enteropathywhich in the opinion of investigator precludes safe treatment with GLP-1 RA.
  • Hypoglycaemia unawareness, or history of frequent or severe hypoglycaemia (in the opinion of the investigator)
  • Personal history of chronic pancreatitis, or acute pancreatitis within 180 days of screening
  • Known current uncontrolled or unstable retinopathy (by medical history)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Davita UT Southwestern - Oak Cliff

Dallas, Texas, 75224, United States

Location

DaVita UT Southwestern - East Dallas

Dallas, Texas, 75228, United States

Location

DaVita UT Southwestern - Preston

Dallas, Texas, 75240, United States

Location

DaVita UT Southwestern - Irving

Irving, Texas, 75062, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ildiko Lingvay, MD, MPH, MSCS

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The randomization and each dispensation will be performed by blinded study staff using an electronic system coded with the randomization code, to ensure all study personnel remains blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled, trial comparing semaglutide subcutaneously weekly versus matched placebo
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 18, 2023

Study Start

December 5, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)