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

First listed
Nov 29, 2023
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-

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By research site
University of Minnesota· Minneapolis, MN

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