SGLT2 Inhibitor for Cystic Fibrosis-related Diabetes

Phase 2 & 3

Recruiting

Research Sponsored by Amir Moheet

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult subjects 18 years or older with CFRD and on insulin treatment

Be older than 18 years old

Must not have

History of recurrent genital or urinary tract infections

Less than 12 weeks since start of a new CFTR corrector/modulator therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Summary

This trial tests if a new diabetes drug is safe and tolerated in overweight/obese patients with chronic fatigue-related diabetes.

Who is the study for?

This trial is for overweight or obese adults (BMI >25) aged 18+ with Cystic Fibrosis-related Diabetes (CFRD) who are on insulin. Participants capable of pregnancy must use effective contraception. Excluded are those with recent severe lung issues, chronic kidney disease, organ transplants, non-English speakers, new CFTR therapy users within 12 weeks, Type 1 diabetes patients, and individuals with a history of certain infections or eating disorders.

What is being tested?

The study tests the safety and effectiveness of Empagliflozin in CFRD patients compared to a placebo. It's designed as a double-blind crossover study—meaning participants will receive both the drug and placebo at different times without knowing which one they're taking—with a break period between treatments.

What are the potential side effects?

Potential side effects from Empagliflozin may include urinary tract infections, dehydration leading to low blood pressure, ketoacidosis (a serious condition related to diabetes), genital yeast infections in women and men, increased cholesterol levels and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with cystic fibrosis-related diabetes and on insulin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had repeated infections in my genital or urinary areas.

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I started a new CFTR therapy less than 12 weeks ago.

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I have a positive GAD 65 antibody or low fasting C-peptide level.

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I have had diabetic ketoacidosis in the past.

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My kidney function is reduced (eGFR < 60).

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I have had a solid organ transplant.

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I have Type 1 diabetes.

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I have chronic liver disease or my liver tests are three times above the normal limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.