Cystic Fibrosis-related DiabetesPhase 2/3NCT06149793
SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes
A Phase 2/3 study testing Empagliflozin in people with Cystic Fibrosis-related Diabetes and Cystic Fibrosis, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis
- What is being tested?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 31 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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
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.
Read the 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).
- Conditions
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis
- Being tested
- Empagliflozin, Placebo Control
- Keywords
- CFRD, cystic fibrosis, cystic fibrosis related diabetes, empagliflozin
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance, SGLT2 inhibitor
Sodium glucose co-transporter 2 inhibitor
Placebo ControlOther
Placebo Control
| Study group | Role | What they receive |
|---|---|---|
| empagliflozin | Active comparator | randomized to study medication (empagliflozin) 10 mg taken by mouth daily for 4 weeks Receives: Drug: Empagliflozin |
| placebo control | Placebo comparator | randomized to placebo control taken by mouth daily for 4 weeks Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Glucose Monitor (CGM): Percentage of Time in Range 70-180mg/dL
Primary outcome of the study is Continuous Glucose Monitor (CGM): Percentage of Time in Range 70-180mg/dL measured over 4 weeks during each intervention period.
Measured: 4 weeks
Area Under a Curve Glucose
Area under the curve glucose during oral glucose tolerance test done 4 weeks post each intervention. Data collected at time points of 0, 30, 60 and 120 minutes during oral glucose tolerance test.
Measured: 4 weeks
Secondary outcomes (1)
Peak Glucose
Peak glucose level during oral glucose tolerance test. Data collected at time points of 0, 30, 60 and 120 minutes during oral glucose tolerance test.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start8 Jan 2024
- Primary completion3 Jun 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic Fibrosis-related DiabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149793
- Sponsor's protocol ID
- MED-2023-31645
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2023
- Last updated
- 21 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06149793
- Acronym / sponsor ID
- MED-2023-31645
- Conditions
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis
- Keywords
- CFRD, cystic fibrosis, cystic fibrosis related diabetes, empagliflozin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 3 Jun 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Posted 21 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| empagliflozin | Active comparator | Drug: Empagliflozinrandomized to study medication (empagliflozin) 10 mg taken by mouth daily for 4 weeks |
| placebo control | Placebo comparator | Other: Placebo Controlrandomized to placebo control taken by mouth daily for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinAlso: Jardiance, SGLT2 inhibitorSodium glucose co-transporter 2 inhibitor | Drug | empagliflozin |
| Placebo ControlPlacebo Control | Other | placebo control |
Primary outcome
Continuous Glucose Monitor (CGM): Percentage of Time in Range 70-180mg/dL
Time frame: 4 weeks
Primary outcome of the study is Continuous Glucose Monitor (CGM): Percentage of Time in Range 70-180mg/dL measured over 4 weeks during each intervention period.
Area Under a Curve Glucose
Time frame: 4 weeks
Area under the curve glucose during oral glucose tolerance test done 4 weeks post each intervention. Data collected at time points of 0, 30, 60 and 120 minutes during oral glucose tolerance test.
1 secondary outcome
Peak Glucose
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Empagliflozin in people with Cystic Fibrosis-related Diabetes and Cystic Fibrosis, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Glucose Monitor (CGM): Percentage of Time in Range 70-180mg/dL (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.