SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06149793
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

  • Cystic Fibrosis
  • Cystic Fibrosis-related Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Sodium glucose co-transporter 2 inhibitor
  • Placebo Control — OTHER
    Placebo Control

Study Details

This will be a placebo-controlled, randomized, double blind, crossover study with a 4 week wash out period. Collect pilot data on the safety, tolerability, and feasibility of empagliflozin therapy in overweight/obese patients with CFRD to support a future larger randomized controlled trial.

Key Dates

Start date
Jan 8, 2024
Status verified
Jan 2026
Primary completion
Jun 3, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
8 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: empagliflozin
    randomized to study medication (empagliflozin) 10 mg taken by mouth daily for 4 weeks
  • Placebo Comparator: placebo control
    randomized to placebo control taken by mouth daily for 4 weeks

Primary Outcome Measure

Feasibility, safety, tolerability [ Time Frame: Duration of anticipated participation for an individual participant's would be around 15 weeks.Duration anticipated to complete all study procedures, including any long-term follow-up, and data analysis is 24 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455-

Find similar trials in Minneapolis, MN

By research site
University of Minnesota· Minneapolis, MN

Related Studies