Type1 Diabetes MellitusPhase 3CLASS17NCT03979352

Effect of SGLT2i in Conjunction With the Artificial Pancreas on Improving the Glycemia in T1DM in the Outpatient Setting

A Phase 3 study testing empagliflozin and artificial pancreas in people with Type1 Diabetes Mellitus, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Type1 Diabetes Mellitus
What is being tested?: empagliflozin and artificial pancreas
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 2 sitesCanada
Study dates: 1 Aug 2019to 31 Aug 2021
Phase: Phase 3
Are there results?: None posted in the registry

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

Signed and dated written informed consent by the date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation.
Males and females ≥ 18 years of age.
Clinical diagnosis of T1D for at least one year. The diagnosis of T1D is based on the investigator's clinical judgment; C peptide level and antibody determinations are not planned.
Insulin pump therapy use for at least 3 months.
HbA1c ≤ 10%.
eGFR ≥ 60 mL/min/1.73 m² as calculated by the CKD-EPI formula.
Women of child-bearing potential must be ready and able to use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly.

Who cannot join

Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
Renal insufficiency (characterized at eGFR below 60 mmol/l at the beginning of the trial)
History of pheochromocytoma or insulinoma
Beta-blockers at high dose (interference with glucose management).
Chronic acetaminophen treatment (can interfere with glucose sensor measurements).

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Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding).
Current use of other non-insulin adjunct anti-hyperglycemic drug or use within 30 days prior to screening.
Use of loop diuretics (e.g. furosemide, due to possible interference with study drug mechanism of action).
Ongoing or planned pregnancy or breastfeeding.
Severe hypoglycemic episode within one month prior to Visit 1.
Diabetic ketoacidosis in the last 3 months prior to Visit 1.
Current use of glucocorticoid medication except low stable dose and inhaled steroids (can interfere with glucose sensor measurements).
Known or suspected allergy to the trial products.
Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Anticipating a significant change in exercise regimen between initiation of two intervention blocks (i.e. starting or stopping an organized sport).
Recent history of genital or urinary infection (<1 month prior to Visit 1) or history of recurrent urinary tract infections.
Difficulty in using the artificial pancreas system following training.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

McGill University
Montreal, Quebec, H3A 2B4
Sinai Health System
Toronto, Ontario, M5T 3L9

Other trials in Canada

About this study

Official title: Effect of SGLT2 Inhibition on Improving the Glycemic Performance of the Single Hormone Artificial Pancreas Configuration in Type 1 Diabetes in the Outpatient Setting - A Randomized Placebo Controlled Cross-Over Multicentre Clinical Trial

The most advanced configurations of the Artificial Pancreas (AP) have not yet been demonstrated to sufficiently maximize time in target glycemia. One limitation is the challenge of postprandial glycemic control, which currently requires ongoing patient engagement for accurate and detailed bolus dose estimation for meals. Sodium Glucose Linked Transporter 2 Inhibition (SGLT2i) provides an additional mechanism to attenuate post-prandial glycemic excursion, and may represent a strategy that could further alleviate carbohydrate counting burden and improve the performance of AP configurations. This trial aims to compare - using a randomized, masked placebo-controlled, crossover, multicenter design - the efficacy of the SGLT2i empagliflozin 25 mg oral per day each in the setting of single-hormone automated AP and conventional insulin pump therapy on the proportion of time spent in target and in hypoglycemia each during a 4-week day-and-night period. The pilot trial aims to enroll 28 adult patients with type 1 diabetes (T1D) across 2 research sites (one in Toronto and one in Montreal) and includes a 2- week therapy optimization run-in period, 4-weeks for each of the two AP intervention arms, and a 1- week washout in between the pharmacological intervention sequences. Glucose levels will be measured by continuous glucose monitoring (G5, Dexcom Inc.). Insulin will be infused using a subcutaneous infusion pump (t-slim, Tandem Diabetes Care) and communication between pumps and the algorithm will be implemented using Android Smartphone devices and Bluetooth technology communication.

Conditions: Type1 Diabetes Mellitus
Being tested: empagliflozin, artificial pancreas
Keywords: Type 1 Diabetes Mellitus, Empagliflozin, Artificial Pancreas, SGLT2 inhibitor, insulin pump, closed loop
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

empagliflozinDrug
Treatment with empagliflozin 25mg orally once a day
artificial pancreasDevice
Insulin delivery via a closed loop single-hormone artificial pancreas system.

Study groups in NCT03979352
Study group	Role	What they receive
Empagliflozin arm	Active comparator	Participant will be treated by empagliflozin for 8 weeks. During these 8 weeks he will use artificial pancreas to deliver the insulin for 4 weeks and conventional pump therapy for remaining 4 weeks, in a random order. After finishing the entire arm intervention participant will undergo 7 day of washout and enters the placebo arm. Participant and research staff is blinded to arm assignment. Receives: Drug: empagliflozin; Device: artificial pancreas
Placebo arm	Placebo comparator	Participant will take placebo for 8 weeks. During these 8 weeks he will use artificial pancreas to deliver the insulin for 4 weeks and conventional pump therapy for remaining 4 weeks, in a random order. After finishing the entire arm intervention participant will undergo 7 day of washout and enters the empagliflozin arm. Participant and research staff is blinded to arm assignment. Receives: Device: artificial pancreas

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks AP on empagliflozin and 4-weeks AP with placebo
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks AP on empagliflozin and 4-weeks AP with placebo.
Measured: 20 weeks
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks conventional pump therapy on empagliflozin and 4- weeks conventional pump therapy with placebo
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks conventional pump therapy on empagliflozin and 4- weeks conventional pump therapy with placebo.
Measured: 20 weeks
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L on 4- weeks automated AP on empagliflozin when compared to 4-weeks conventional pump therapy on empagliflozin
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L on 4- weeks automated AP on empagliflozin when compared to 4-weeks conventional pump therapy on empagliflozin.
Measured: 20 weeks
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L on 4- weeks automated AP on empagliflozin when compared to 4-weeks conventional pump therapy with placebo
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L on 4- weeks automated AP on empagliflozin when compared to 4-weeks conventional pump therapy with placebo.
Measured: 20 weeks

Secondary outcomes (14)

Percentage of time spent in sensor glucose target range defined as between 3.9 and 10.0 mmol/L compared between 4- weeks conventional pump therapy on empagliflozin and 4-weeks AP on empagliflozin
Percentage of time spent in sensor glucose target range defined as between 3.9 and 10.0 mmol/L compared between 4- weeks conventional pump therapy on empagliflozin and 4-weeks AP on empagliflozin
Measured: 20 weeks
Percentage of time spent in sensor glucose target range defined as between 3.9 and 10.0 mmol/L compared between 4- weeks AP on empagliflozin and 4- weeks AP with placebo
Percentage of time spent in sensor glucose target range defined as between 3.9 and 10.0 mmol/L compared between 4- weeks AP on empagliflozin and 4- weeks AP with placebo.
Measured: 20 weeks
Hypoglycemia: Percentage of time with glucose <3.9 mmol/L applied to each of the primary and secondary outcome comparator groups
Hypoglycemia: Percentage of time with glucose <3.9 mmol/L applied to each of the primary and secondary outcome comparator groups.
Measured: 20 weeks
Percentage of time spent in hypoglycemia, euglycemia and hyperglycemia
Percentage of time spent in the different glucose sensor levels characterized by amount spent between 3.9 and 10.0 mmol/L, 3.9 and 7.8 mmol/L, above 10.0 mmol/L, above 13.9 mmol/L, above 16.7 mmol/l, below 3.9 mmol/L, below 3.3 mmol/L, below 2.8 mmol/L
Measured: 20 weeks
Absolute number of hypoglycemia events I.
Number of hypoglycemic events (> 20 minutes) below 3.3 mmol/L based on sensor glucose levels
Measured: 20 weeks
Absolute number of hypoglycemia events II.
Number of symptomatic hypoglycemic events < 3.9 mmol/l or below 3.3 mmol/l without symptoms
Measured: 20 weeks
Absolute number of hypoglycemia events III.
Number of treated hypoglycemic events
Measured: 20 weeks
Statistical characteristics of glucose profile I.
Area under the curve of hypoglycemic glucose values (below 3.9 mmol/L, 3.3 mmol/L and 2.8 mmol/L)
Measured: 20 weeks
Statistical characteristics of glucose profile II.
Standard deviation of glucose levels
Measured: 20 weeks
Amount of total insulin delivery during interventions
Total insulin delivery measured by mean of units per day
Measured: 20 weeks
Change in HbA1c
Change in HbA1c from baseline to after the first intervention and from the end of the first intervention to the end of the treatment period.
Measured: 20 weeks
Mean fasting capillary ketone levels
Mean fasting capillary ketone levels.
Measured: 20 weeks
Number of episodes of diabetic ketoacidosis
Number of episodes of diabetic ketoacidosis
Measured: 20 weeks
Number of technical adverse events
Number of events when algorithm crashes or needs to be overridden for safety reasons.
Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201931 Aug 2021

First posted7 Jun 2019
Study start1 Aug 2019
Primary completion31 Aug 2021
Study completion31 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type1 Diabetes MellitusStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03979352
Sponsor's protocol ID: CLASS 17
Acronym: CLASS17
Status last verified: Nov 2019
First submitted: 13 Apr 2019
Last updated: 7 Jun 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of SGLT2 Inhibition on Improving the Glycemic Performance of the Single Hormone Artificial Pancreas Configuration in Type 1 Diabetes in the Outpatient Setting - A Randomized Placebo Controlled Cross-Over Multicentre Clinical Trial
ClinicalTrials.gov ID: NCT03979352
Acronym / sponsor ID: CLASS17 / CLASS 17
Conditions: Type1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus, Empagliflozin, Artificial Pancreas, SGLT2 inhibitor, insulin pump, closed loop
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre
Study start: 1 Aug 2019 (actual)
Primary completion: 31 Aug 2021 (actual)
Study completion: 31 Aug 2021 (actual)
First posted: 7 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Empagliflozin arm	Active comparator	Drug: empagliflozin, Device: artificial pancreasParticipant will be treated by empagliflozin for 8 weeks. During these 8 weeks he will use artificial pancreas to deliver the insulin for 4 weeks and conventional pump therapy for remaining 4 weeks, in a random order. After finishing the entire arm intervention participant will undergo 7 day of washout and enters the placebo arm. Participant and research staff is blinded to arm assignment.
Placebo arm	Placebo comparator	Device: artificial pancreasParticipant will take placebo for 8 weeks. During these 8 weeks he will use artificial pancreas to deliver the insulin for 4 weeks and conventional pump therapy for remaining 4 weeks, in a random order. After finishing the entire arm intervention participant will undergo 7 day of washout and enters the empagliflozin arm. Participant and research staff is blinded to arm assignment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Signed and dated written informed consent by the date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation.
Males and females ≥ 18 years of age.
Clinical diagnosis of T1D for at least one year. The diagnosis of T1D is based on the investigator's clinical judgment; C peptide level and antibody determinations are not planned.
Insulin pump therapy use for at least 3 months.
HbA1c ≤ 10%.

Key exclusion criteria (18 listed)

Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
Renal insufficiency (characterized at eGFR below 60 mmol/l at the beginning of the trial)
History of pheochromocytoma or insulinoma
Beta-blockers at high dose (interference with glucose management).

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
empagliflozinTreatment with empagliflozin 25mg orally once a day	Drug	Empagliflozin arm
artificial pancreasInsulin delivery via a closed loop single-hormone artificial pancreas system.	Device	Empagliflozin arm, Placebo arm

Primary outcome

Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks AP on empagliflozin and 4-weeks AP with placebo
Time frame: 20 weeks
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks AP on empagliflozin and 4-weeks AP with placebo.
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks conventional pump therapy on empagliflozin and 4- weeks conventional pump therapy with placebo
Time frame: 20 weeks
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks conventional pump therapy on empagliflozin and 4- weeks conventional pump therapy with placebo.
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L on 4- weeks automated AP on empagliflozin when compared to 4-weeks conventional pump therapy on empagliflozin
Time frame: 20 weeks
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L on 4- weeks automated AP on empagliflozin when compared to 4-weeks conventional pump therapy on empagliflozin.
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L on 4- weeks automated AP on empagliflozin when compared to 4-weeks conventional pump therapy with placebo
Time frame: 20 weeks
Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L on 4- weeks automated AP on empagliflozin when compared to 4-weeks conventional pump therapy with placebo.

14 secondary outcomes

Percentage of time spent in sensor glucose target range defined as between 3.9 and 10.0 mmol/L compared between 4- weeks conventional pump therapy on empagliflozin and 4-weeks AP on empagliflozin
Time frame: 20 weeks
Percentage of time spent in sensor glucose target range defined as between 3.9 and 10.0 mmol/L compared between 4- weeks AP on empagliflozin and 4- weeks AP with placebo
Time frame: 20 weeks
Hypoglycemia: Percentage of time with glucose <3.9 mmol/L applied to each of the primary and secondary outcome comparator groups
Time frame: 20 weeks
Percentage of time spent in hypoglycemia, euglycemia and hyperglycemia
Time frame: 20 weeks
Absolute number of hypoglycemia events I.
Time frame: 20 weeks
Absolute number of hypoglycemia events II.
Time frame: 20 weeks
Absolute number of hypoglycemia events III.
Time frame: 20 weeks
Statistical characteristics of glucose profile I.
Time frame: 20 weeks
Statistical characteristics of glucose profile II.
Time frame: 20 weeks
Amount of total insulin delivery during interventions
Time frame: 20 weeks
Change in HbA1c
Time frame: 20 weeks
Mean fasting capillary ketone levels
Time frame: 20 weeks
Number of episodes of diabetic ketoacidosis
Time frame: 20 weeks
Number of technical adverse events
Time frame: 20 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
Individual participant dataSharing planned: No

Related trials for Type1 Diabetes Mellitus

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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
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A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
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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.

Bruce Perkins, MD principal investigator

Samuel Lunenfeld Research Institute

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing empagliflozin and artificial pancreas in people with Type1 Diabetes Mellitus, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 2 sites in Canada.

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 7 inclusion and 18 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: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of time spent in sensor glucose target range defined as between 3.9 and 7.8 mmol/L compared between 4- weeks AP on empagliflozin and 4-weeks AP with placebo (time frame: 20 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03979352.

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 7 Jun 2022.