ADJUnct Semaglutide Treatment in Type 1 Diabetes

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Viral N. Shah
Study ID
NCT05537233
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Semaglutide up to 1 mg per week in addition to standard closed-loop therapy
  • Placebo — DRUG
    Injection placebo up to 1 mg per week in addition to standard closed-loop therapy

Study Details

The purpose of this study is to assess the use of once weekly semaglutide injection in inadequately controlled obese adults with type 1 diabetes (T1D) using FDA-approved hybrid closed-loop therapies.

Key Dates

Start date
Apr 11, 2023
Status verified
Aug 2025
Primary completion
Aug 6, 2024
Completion
Aug 6, 2024

Study Design

Enrollment
115 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy
  • Placebo Comparator: Control
    Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy

Primary Outcome Measure

Proportion of Adults With T1D Achieving Composite Outcome (CGM-measured Time in Range (TIR)>70% With Time Below Range (TBR) of <4% and Reduction in Body Weight by 5%) at 26 Weeks in the Semaglutide Group Compared to Placebo Group [ Time Frame: 26 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
Barbara Davis Center for DiabetesAuroraColorado80045-
Iowa Diabetes Research CenterWest Des MoinesIowa50265-
Henry Ford HospitalDetroitMichigan48202-
Harold Schnitzer Diabetes Health CenterPortlandOregon97239-

Related coverage on Hipa.ai

Find similar trials in Aurora, CO

By condition
Obesity / overweightType 1 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Barbara Davis Center for Diabetes· Aurora, COIowa Diabetes Research Center· West Des Moines, IAHenry Ford Hospital· Detroit, MIHarold Schnitzer Diabetes Health Center· Portland, OR

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