Basal Plus GLP1-ra on Glycemic Variability in CKD

Sponsor
Elaine Chow
Study ID
NCT05218915
Phase
PHASE4
Status
Completed

Conditions

  • Diabetes Mellitus
  • Diabetic Kidney Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dulaglutide — DRUG
    Dulaglutide once weekly subcutaneous
  • Insulin Degludec — DRUG
    Insulin degludec once daily
  • Continuous glucose monitor — DEVICE
    Dexcom G6 CGM system

Study Details

To compare GLP-1 RA plus basal insulin (BGLP) versus basal-bolus (BB) insulin regimens on glycemic variability (GV) and time in range (TIR) in diabetes patients CKD stage 3-4

Key Dates

Start date
Jan 28, 2022
Status verified
Nov 2024
Primary completion
Oct 30, 2024
Completion
Oct 30, 2024

Study Design

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

Arms

  • Experimental: GLP1-ra plus basal insulin (BGLP)
    Dulaglutide and insulin degludec in combination with CGM
  • Active Comparator: Basal bolus insulin (BB)
    Insulin aspart/lispro and insulin degludec in combination with CGM

Primary Outcome Measure

Glycemic variability [ Time Frame: 16 weeks ]

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