Empagliflozin for Type 1 Diabetes

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Melissa-Rosina Pasqua, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Must be taking: Insulin

Must not be taking: GLP1 agonists, Glucocorticoids

Disqualifiers: Pregnancy, Breastfeeding, Severe hypoglycemia, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this 26-week multicenter, randomized, parallel, placebo-controlled trial is to test the effectiveness of empagliflozin use in conjunction with automated insulin delivery (AID) to improve glucose control in individuals with type 1 diabetes who do not meet target recommendations for time in range (3.9-10.0 mmol/L). The main question it aims to answer is: - Will use of empagliflozin (2.5 mg/day) increase time spent in the target range of 3.9 to 10.0 mmol/L compared to placebo for individuals on an AID system who do not meet glycemic targets? Participants will either take 2.5 mg of empagliflozin or a placebo daily for 26 weeks while remaining on their current AID system.

Will I have to stop taking my current medications?

The trial requires that participants do not use any anti-hyperglycemic agents other than insulin within 2 weeks before starting, and no GLP1-Receptor Agonists or high doses of glucocorticoids within 1 month before starting. If you are on these medications, you may need to stop them before joining the trial.

What data supports the effectiveness of the drug empagliflozin for treating type 1 diabetes?

Empagliflozin, a drug used for type 2 diabetes, has been shown to help control blood sugar levels and reduce body weight and blood pressure. It also lowers the risk of heart-related issues in people with heart failure, even if they don't have diabetes. While these benefits are seen in type 2 diabetes and heart failure, similar effects might be expected in type 1 diabetes, although direct evidence is not provided. ^{1 2 3 4 5}

Is empagliflozin safe for humans?

Empagliflozin (Jardiance) is generally safe for humans, but it can cause some side effects like genital infections, especially in women, and a slight increase in mild urinary tract infections. It may also lead to low blood pressure and fluid loss, so monitoring is important, especially for those at risk. ^{2 4 5 6 7}

How does the drug empagliflozin differ from other treatments for type 1 diabetes?

Empagliflozin is unique because it works by preventing the kidneys from reabsorbing glucose, leading to its excretion in urine, which is different from most diabetes treatments that focus on insulin regulation. This mechanism also helps reduce body weight and blood pressure, offering additional benefits beyond blood sugar control. ^{1 2 5 6 8}

Research Team

Melissa-Rosina Pasqua, MD

Principal Investigator

Research Institute of the McGill University Health Centre

Eligibility Criteria

Adults over 18 with type 1 diabetes for at least a year, using an automated insulin delivery system for 3+ months but not meeting glucose control targets. They must agree to effective birth control if of child-bearing age.

Inclusion Criteria

I am 18 years old or older.

I agree to use effective birth control and avoid pregnancy during the trial.

I have used an advanced AID system for at least 3 months.

Exclusion Criteria

Breastfeeding

I have been taking high doses of steroids for the last month or less.

I have had a severe low blood sugar episode that caused a seizure, unconsciousness, or an ER visit in the last month.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 2.5 mg of empagliflozin or a placebo daily for 26 weeks while using their automated insulin delivery system

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Empagliflozin (SGLT2 Inhibitor)

Trial Overview The trial is testing whether adding Empagliflozin (2.5 mg daily) to current AID systems helps adults with type 1 diabetes stay within their target blood sugar range better than a placebo does over a period of 26 weeks.

Participant Groups

Group I: Empagliflozin 2.5 mg daily Experimental Treatment 1 Intervention

Empagliflozin is a sodium/glucose cotransporter 2 inhibitor (SGLT2i) that inhibits glucose reabsorption in the kidney. In this study, a capsule of empagliflozin 2.5 mg will be taken daily in conjunction with the participant's personal automated insulin delivery system for 26 weeks.

Group II: Placebo Active Control 1 Intervention

As a control, a placebo capsule will be taken daily in conjunction with the participant's personal automated insulin delivery system for 26 weeks.

Empagliflozin is already approved in Canada, Japan for the following indications:

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

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Dr. Lucie Opatrny

McGill University Health Centre/Research Institute of the McGill University Health Centre

President and Executive Director since 2023

MDCM and Master's in Epidemiology and Biostatistics from McGill University, Master's in Healthcare Management and Diploma in Advanced Negotiation from Harvard University

Dr. Patrizia Cavazzoni

McGill University Health Centre/Research Institute of the McGill University Health Centre

Chief Medical Officer

MD from McGill University, residency in Psychiatry and fellowship in Mood Disorders at the University of Ottawa

Diabetes Canada

Collaborator

Trials

13

Recruited

1,200+

Findings from Research

In the EMPEROR-Reduced study involving over 3700 participants with chronic heart failure and reduced ejection fraction, empagliflozin significantly reduced the risk of hospitalization for heart failure complications (13.2% vs. 18.3% for placebo) over an average of 16 months.

Empagliflozin also showed a lower incidence of serious kidney problems (1.6% vs. 3.1% for placebo), indicating its potential safety and efficacy in managing heart failure, although it was associated with a higher rate of genital tract infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. Zannad, F., Macari, S.[2023]

Empagliflozin (Jardiance) has been associated with a significant reduction in cardiovascular mortality among patients with type 2 diabetes and established cardiovascular disease, although the exact mechanism for this benefit is not yet understood.

There is uncertainty regarding whether empagliflozin may also increase the risk of fractures, a concern raised with another SGLT2 inhibitor, canagliflozin (Invokana), and all SGLT2 inhibitors are noted to have only modest effectiveness in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SGLT2 inhibitors: new reports. [2019]

Empagliflozin, an SGLT2 inhibitor, is effective in improving blood sugar control in adults with type 2 diabetes, especially when metformin is not suitable.

In addition to managing diabetes, empagliflozin also aims to reduce cardiovascular risks associated with the condition, highlighting its dual role in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

▼ Empagliflozin, diabetes and outcomes. [2017]

Empagliflozin effectively reduces blood sugar levels in patients with type 2 diabetes by preventing glucose reabsorption, leading to a loss of about 70 grams of glucose per day, which also contributes to weight loss.

In addition to its blood sugar-lowering effects, empagliflozin has been shown to slightly decrease blood pressure and has been approved for use in the European Union since May 2014, often in combination with other diabetes medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Empagliflozin - the new representative of SGLT2 transporter inhibitors for the treatment of patients with diabetes 2 type]. Prázný, M., Slíva, J.[2018]

Empagliflozin (Jardiance®) is an effective treatment for type 2 diabetes (T2D) that works by inhibiting the sodium glucose cotransporter-2 (SGLT2), and it also offers cardioprotective and renoprotective benefits, making it particularly suitable for patients with cardiovascular disease (CVD) and chronic kidney disease (CKD).

While empagliflozin is generally well-tolerated and easy to administer, it does have some side effects and contraindications that need to be considered, highlighting the importance of evaluating its benefits against potential risks in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dual role of empagliflozin: Cardio renal protection in T2DM patients. Shafiq, A., Mahboob, E., Samad, MA., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Diabetes Drug Now Approved for Heart Failure. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

SGLT2 inhibitors: new reports. [2019]

4. England pubmed.ncbi.nlm.nih.gov

▼ Empagliflozin, diabetes and outcomes. [2017]

5. Belgium pubmed.ncbi.nlm.nih.gov

[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. [2022]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

[Empagliflozin - the new representative of SGLT2 transporter inhibitors for the treatment of patients with diabetes 2 type]. [2018]

7. England pubmed.ncbi.nlm.nih.gov

The dual role of empagliflozin: Cardio renal protection in T2DM patients. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Case of Severe Metabolic Acidosis due to Jardiance-Induced Euglycemic Diabetic Ketoacidosis. [2021]