SGLT2 Inhibitor for Cystic Fibrosis-related Diabetes
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Amir Moheet
Must be taking: Insulin
Must not be taking: Glucocorticoids
Disqualifiers: Type 1 diabetes, Pregnancy, Chronic liver disease, Chronic kidney disease, others
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but there is a 4-week washout period (time without taking certain medications) mentioned. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Empagliflozin (Jardiance) for treating cystic fibrosis-related diabetes?
Empagliflozin (Jardiance) is effective in lowering blood sugar levels in people with type 2 diabetes by preventing glucose reabsorption in the kidneys, which also helps reduce body weight and blood pressure. While this data is specific to type 2 diabetes, the drug's ability to lower blood sugar may be beneficial for managing cystic fibrosis-related diabetes as well.
12345How does the drug Empagliflozin differ from other treatments for cystic fibrosis-related diabetes?
Empagliflozin is unique because it works by blocking a protein in the kidneys that normally helps reabsorb sugar back into the blood, leading to more sugar being excreted in urine. This mechanism is different from other diabetes treatments that often focus on insulin or its effects, and it also helps reduce body weight and blood pressure, which can be beneficial for overall health.
12567Eligibility Criteria
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.Inclusion Criteria
I am 18 or older with cystic fibrosis-related diabetes and on insulin.
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 weigh more than what is considered healthy for your height.
Exclusion Criteria
You are allergic to empagliflozin or any ingredients in Jardiance.
I have had repeated infections in my genital or urinary areas.
You have a history of an eating disorder.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to receive either empagliflozin or placebo for 4 weeks
4 weeks
4 visits (in-person)
Washout
Participants undergo a 4-week washout period between treatment phases
4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 weeks
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: empagliflozinActive Control1 Intervention
randomized to study medication (empagliflozin) 10 mg taken by mouth daily for 4 weeks
Group II: placebo controlPlacebo Group1 Intervention
randomized to placebo control taken by mouth daily for 4 weeks
Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
🇺🇸 Approved in United States as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Cardiovascular risk reduction
🇨🇦 Approved in Canada as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
🇯🇵 Approved in Japan as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
Amir MoheetLead Sponsor
References
[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. [2022]Empagliflozin is a new inhibitor of sodiumglucose cotransporters type 2 (SGLT2) for the treatment of type 2 diabetes mellitus (T2DM). Its specific action inhibits glucose reabsorption in renal tubules and thus promotes glucosuria. This effect results in a reduction in fasting and postprandial glycaemia and a decrease of glycated haemoglobin (HbA(Ic)), independently of insulin. Furthermore, calorie urinary loss promotes weight reduction and osmotic diuresis lowers arterial blood pressure. The efficacy of empagliflozin increases according to the level of hyperglycaemia but decreases in patients with renal insufficiency. In 24 to 104-week controlled trials versus placebo, empagliflozin reduces HbA(1c) (approximately 0.8%), without hypoglycaemia (except in patients already treated with insulin or sulphonylureas). This improvement in glucose control is rather similar to that observed with active comparators (metformin, glimepiride or sitagliptin), with the advantage for empagliflozin of reducing body weight (approximately 2 kg) and blood pressure (systolic approximately 4 mm Hg and diastolic approximately 2 mm Hg). Empagliflozin has shown a cardiovascular protection in the EMPA-REG OUTCOME trial. Mycotic genital infections occur more frequently, especially in women, while a negligible increase in mild urinary tract infections may be observed. The risk of hypotension and volume depletion is low, although it should be carefully checked in more fragile and at risk patients. Empagliflozin (Jardiance), which is commercialized at the doses of 10 mg and 25 mg once daily, is indicated for the treatment of T2DM and reimbursed in Belgium with conditions as add-on to a background glucose-lowering therapy.
Empagliflozin (Jardiance): A Novel SGLT2 Inhibitor for the Treatment of Type-2 Diabetes. [2020]Empagliflozin (Jardiance): a novel SGLT2 inhibitor for the treatment of type-2 diabetes.
Empagliflozin: a review of its use in patients with type 2 diabetes mellitus. [2021]Oral empagliflozin (Jardiance(®)), a sodium glucose cotransporter-2 (SGLT2) inhibitor, is a convenient once-daily treatment for adult patients with type 2 diabetes mellitus. By inhibiting reabsorption of glucose from the proximal tubules in the kidney via inhibition of SGLT2, empagliflozin provides a novel insulin-independent mechanism of lowering blood glucose. In several phase III trials (≤104 weeks' duration; typically 24 weeks' duration) and extension studies (typically ≥76 weeks' treatment), empagliflozin monotherapy or add-on therapy to other antihyperglycaemics, including insulin, improved glycaemic control and reduced bodyweight and systolic blood pressure in adult patients with type 2 diabetes. In a large phase III trial, as add-on therapy to metformin, empagliflozin was shown to be noninferior to glimepiride at 52 and 104 weeks and superior to glimepiride at 104 weeks, in terms of reductions in glycated haemoglobin level (primary endpoint). Empagliflozin was well tolerated by participants in these clinical trials, with most adverse events being mild or moderate in intensity. Empagliflozin treatment appeared to have no intrinsic risk of hypoglycaemia, although hypoglycaemia occurred more frequently when empagliflozin was coadministered with insulin and/or a sulfonylurea. With its insulin-independent mechanism of action, empagliflozin monotherapy or combination therapy with other antidiabetic drugs, including insulin, provides a useful addition to the therapeutic options for the management of type 2 diabetes. This article reviews the pharmacological properties and clinical use of empagliflozin in patients with type 2 diabetes.
Long-term effectiveness and safety of quadruple combination therapy with empagliflozin versus dapagliflozin in patients with type 2 diabetes: 3-year prospective observational study. [2021]To investigate the long-term effectiveness and safety of two distinct sodium-glucose co-transporter 2 (SGLT2) inhibitors, empagliflozin and dapagliflozin, in inadequately controlled type 2 diabetes (T2D) despite a combined administration of metformin, glimepiride and dipeptidyl peptidase-4 inhibitor.
Empagliflozin, an SGLT2 inhibitor for the treatment of type 2 diabetes mellitus: a review of the evidence. [2018]To review available studies of empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor approved in 2014 by the European Commission and the United States Food and Drug Administration for the treatment of type 2 diabetes mellitus (T2DM).
▼ Empagliflozin, diabetes and outcomes. [2017]The prevalence of type 2 diabetes is rising, and in 2015 more than 5% of adults in the UK were affected by this condition.(1,2) Management of type 2 diabetes includes encouraging lifestyle changes (increased exercise, modification of diet and smoking cessation) alongside the provision of medication to minimise long-term complications and manage blood sugar control while avoiding unwanted effects of drug treatment.(3) Of particular importance, people with type 2 diabetes are at increased risk of cardiovascular disease, and therefore the aims of treatment also include modification of associated risk factors.(2-5)▼ Empagliflozin (Jardiance-Boehringer Ingelheim) is the third sodium-glucose co-transporter-2 (SGLT2) inhibitor licensed for use in the UK. It was launched in August 2014, and acts in a similar way to the other SGLT2 inhibitors, ▼ dapagliflozin and ▼ canagliflozin, by inhibiting renal glucose resorption and promoting glycosuria.(6) It is indicated for the treatment of type 2 diabetes in adults to improve glycaemic control, as monotherapy when metformin cannot be used, and in combination with other glucose-lowering drugs including insulin. Here we review the evidence for empagliflozin and discuss the results of a recent study that assessed cardiovascular outcomes.
SGLT2 inhibitors: new reports. [2019]A significant decrease in cardiovascular mortality has been reported with use of the SGLT2 inhibitor empagliflozin (Jardiance) to treat patients with type 2 diabetes who have established cardiovascular disease. The mechanism of this reduction is unclear, and these results may not apply to patients with type 2 diabetes and less advanced cardiovascular disease. Whether the increase in fractures reported with canagliflozin (Invokana) could also occur with empagliflozin remains to be established. All SGLT2 inhibitors are only modestly effective for treatment of diabetes.