Efficacy and Safety of SGLT2 Inhibitor Therapy in Overweight and Obese Subjects With Cystic Fibrosis-related Diabetes: a Pilot Study

Sponsor

Amir Moheet (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06149793

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis-related Diabetes Cystic Fibrosis	Drug: Empagliflozin Other: Placebo Control	Phase 2/Phase 3

Detailed Description

The overall goal of this proposal is to collect pilot data for safety and feasibility metrics to support a future larger randomized controlled trial. In this study, we will examine the safety and tolerability of Sodium glucose co-transporter 2 inhibitor (SGLT2i) empagliflozin as an add-on therapy to insulin for overweight/obese adult patients with CFRD. We hypothesize that empagliflozin will be safe, well tolerated and will improve glycemic control in overweight/obese adult patients with CFRD.

Specific Aim 1: 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.

Hypothesis 1: Empagliflozin will be safe and well tolerated, with no evidence for electrolyte abnormalities, metabolic acidosis, ketosis or increased risk of severe hypoglycemia in overweight/obese adults people with CFRD.

Specific Aim 2: Collect preliminary data to evaluate the effect of empagliflozin on glycemic outcomes.

Hypothesis 2: Treatment with empagliflozin will improve glycemic control as indicated by glucose levels as measured by oral glucose tolerance test (OGTT), and on glycemic outcomes as measured by continuous glucose monitoring (CGM).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Investigator)

Masking Description:

double-blind

Primary Purpose:

Treatment

Official Title:

Empagliflozin in CFRD: Efficacy and Safety of SGLT2 Inhibitor Therapy in Overweight and Obese Subjects With Cystic Fibrosis-related Diabetes: a Pilot Study

Anticipated Study Start Date :

Dec 30, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: empagliflozin randomized to study medication (empagliflozin) 10 mg taken by mouth daily for 4 weeks	Drug: Empagliflozin Sodium glucose co-transporter 2 inhibitor Other Names: Jardiance SGLT2 inhibitor
Placebo Comparator: placebo control randomized to placebo control taken by mouth daily for 4 weeks	Other: Placebo Control Placebo Control

Arm

Intervention/Treatment

Active Comparator: empagliflozin

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

Drug: Empagliflozin

Sodium glucose co-transporter 2 inhibitor

Other Names:

Jardiance

SGLT2 inhibitor

Placebo Comparator: placebo control

randomized to placebo control taken by mouth daily for 4 weeks

Other: Placebo Control

Placebo Control

Outcome Measures

Primary Outcome Measures

Feasibility, safety, tolerability [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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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)