SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes

NCT06149793 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MED-2023-31645
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis; Cystic Fibrosis-related Diabetes

Keywords

CFRD; cystic fibrosis; cystic fibrosis related diabetes; empagliflozin

Outcome Measures

Primary Outcomes (1)

• Feasibility, safety, tolerability

  The primary outcomes are related to feasibility, including safety and treatment tolerability. Safety will be evaluated as the proportion (in %) of participants who experience a serious adverse event during the study. Tolerability will be evaluated as the proportion (in %) of participants who discontinue their assigned treatment due to side effects.

  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.

Study Arms (2)

empagliflozin

ACTIVE COMPARATOR

randomized to study medication (empagliflozin) 10 mg taken by mouth daily for 4 weeks

Drug: Empagliflozin

placebo control

PLACEBO COMPARATOR

randomized to placebo control taken by mouth daily for 4 weeks

Other: Placebo Control

Interventions

Empagliflozin DRUG

Sodium glucose co-transporter 2 inhibitor

Also known as: Jardiance, SGLT2 inhibitor

empagliflozin

Placebo Control OTHER

Placebo Control

placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects 18 years or older with CFRD and on insulin treatment
• BMI \>25 kg/m2
• A participant who is capable of becoming pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study. These methods could include one of the following 1. Complete abstinence from sexual intercourse; 2. Tubal ligation; 3. Use combination of two forms of contraception during the study including, oral, injectable, or implanted hormonal contraceptives, intrauterine device or barrier method.

You may not qualify if:

• acute pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to baseline study procedures
• less than 12 weeks since start of a new CFTR corrector/modulator therapy
• type 1 diabetes
• Positive GAD 65 antibody or low fasting C-peptide (below the normal reference range of the lab)
• A history of diabetic ketoacidosis
• history of recurrent genital or urinary tract infections
• pregnancy or lactation
• prior solid organ transplant
• Chronic liver disease (based on problem list in medical records or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times elevated above the upper limit of normal.
• chronic kidney disease (eGFR \< 60mL/min/1.73 m2)
• Hypersensitivity to empagliflozin or any excipients of Jardiance
• History of eating disorder
• Non-English speakers and those unable to read in English • Diminished capacity to consent (study staff will utilize the MacCAT-CR for assessment)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

empagliflozin; Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model 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.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 29, 2023
• Study Start: January 8, 2024
• Primary Completion: June 3, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)