Glucose and Ketone Monitoring for Type 1 Diabetes

Overseen By Program Manager, MS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, San Diego

Must be taking: Insulin

Must not be taking: SGLT-2i, Pramlintide, Metformin

Disqualifiers: Pregnancy, Type 2 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a dual glucose and ketone monitor can reduce side effects for people with type 1 diabetes taking sotagliflozin, a medication for managing blood sugar levels. Participants will alternate between two different doses of the drug over several weeks to assess its effects. The trial suits individuals who have managed type 1 diabetes for over a year, use insulin regularly, and currently use a continuous glucose monitor. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to the advancement of diabetes treatment.

Do I have to stop taking my current medications for the trial?

If you are currently taking diabetes medications other than insulin, you will need to stop them at least one month before the trial. If you are on a stable dose of GLP-1 receptor antagonist and not experiencing frequent vomiting, you may continue with it.

What prior data suggests that this dual continuous glucose and ketone monitor is safe for use in people with type 1 diabetes?

Research has shown that sotagliflozin is generally well-tolerated by people with diabetes. In one study, participants taking sotagliflozin experienced fewer severe low blood sugar episodes compared to those not taking it. Specifically, 7% of people on a 200 mg dose and 4% on a 400 mg dose experienced severe low blood sugar, compared to 17% of those taking a placebo.

However, some side effects require attention. The risk of diabetic ketoacidosis (a serious condition where the body produces too many blood acids) was higher in those taking sotagliflozin. Additionally, some participants experienced mild infections.

Overall, evidence suggests that sotagliflozin is safe for many people when used correctly, but monitoring for these side effects is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Sotagliflozin is unique because it offers a dual action approach for managing Type 1 diabetes, unlike most current treatments which focus solely on insulin regulation. This medication targets both SGLT1 and SGLT2 proteins, which play a role in glucose absorption and excretion, potentially providing better blood sugar control and reducing the risk of hypoglycemia. Researchers are excited about sotagliflozin because it could offer improved glycemic control and additional benefits, such as weight loss and blood pressure reduction, setting it apart from standard insulin therapies.

What evidence suggests that this trial's treatments could be effective for type 1 diabetes?

Research has shown that sotagliflozin can help people with type 1 diabetes by better controlling blood sugar levels and reducing the risk of low blood sugar episodes. Studies have also found that it can stabilize blood pressure and lower heart-related risks. Additionally, sotagliflozin may aid in weight loss and improve both blood sugar and other health outcomes. Importantly, in one study, patients who took sotagliflozin with insulin experienced a decrease in their HbA1c levels, an important measure of blood sugar control. Overall, evidence suggests that sotagliflozin could effectively manage type 1 diabetes. Participants in this trial will receive different dosages of sotagliflozin in separate treatment arms to further evaluate its effectiveness. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Type 1 Diabetes who are interested in managing their condition using a study drug called sotagliflozin. Participants must meet certain health criteria to join, but specific inclusion and exclusion details aren't provided.

Inclusion Criteria

Individuals able to cause a pregnancy must be willing to use a clinically acceptable method of contraception during the entire study and for an additional 2 weeks after the end of the treatment period

Currently using a Continuous Glucose Monitoring (CGM) system

Hemoglobin A1c ≤10% at the time of screening

Exclusion Criteria

Individuals who are currently pregnant or lactating/breastfeeding, or planning to become pregnant within 10 months after screening

History or evidence of clinically significant disorder or condition that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion

Any other condition(s) that might reduce the chance of obtaining study data, or that might cause safety concerns, or that might compromise the ability to give truly informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sotagliflozin in a cross-over design with two doses (200mg and 400mg) for 6 weeks each, separated by a 2-week washout period

14 weeks

12 visits (MDI), 16 visits (HCL)

Open-label extension

HCL participants continue with open-label 400mg sotagliflozin for an additional 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dual Continuous Glucose and Ketone Monitor
• Sotagliflozin

Trial Overview

The trial tests if monitoring glucose and ketone levels continuously can help reduce side effects when taking sotagliflozin at different doses (low or high) for Type 1 Diabetes management.

How Is the Trial Designed?

Group I: Treatment Group B Experimental Treatment 3 Interventions

400mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 200mg sotagliflozin for 6 weeks

Group II: Treatment Group A Experimental Treatment 3 Interventions

200mg sotagliflozin for 6 weeks, washout for 2 weeks, then receive 400mg sotagliflozin for 6 weeks

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Lexicon Pharmaceuticals

Industry Sponsor

Trials

67

Recruited

24,400+

Dr. Mike Exton

Lexicon Pharmaceuticals

Chief Executive Officer

PhD in Neuroscience from the University of Newcastle and PhD in Immunology from the University of Essen, Germany

Dr. Craig Granowitz

Lexicon Pharmaceuticals

Chief Medical Officer since 2021

MD

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12170572/

Safety and efficacy of adjuvant Sotagliflozin therapy in ...

In T1D patients, Sotagliflozin adjunct therapy improves blood glycemia, stabilizes blood pressure, and reduces cardiovascular risk factors.

2.

jmcp.org

jmcp.org/doi/10.18553/jmcp.2025.31.7.641

Cost-effectiveness analysis model for sotagliflozin ...

Sotagliflozin slowed rates of dialysis and transplant over a 10-year time frame, decreased mortality, and was found to provide good value for ...

3.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1708337

Effects of Sotagliflozin Added to Insulin in Patients with ...

In phase 2 studies, the administration of sotagliflozin improved glycemic control and lowered body weight among patients with type 1 or 2 ...

4.

bmj.com

bmj.com/content/365/bmj.l1328

Efficacy and safety of dual SGLT 1/2 inhibitor sotagliflozin ...

In type 1 diabetes, sotagliflozin improves glycaemic and non-glycaemic outcomes and reduces hypoglycaemia rate and severe hypoglycaemia.

5.

valueinhealthjournal.com

valueinhealthjournal.com/article/S1098-3015(25)01985-0/fulltext

EE257 Cost-Effectiveness of Sotagliflozin for Patients With ...

Efficacy data (inTandem3 randomized controlled trial) indicated that sotagliflozin+insulin lowered HbA1c by 0.46 percentage points relative to insulin alone.

6.

frontiersin.org

frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2022.968478/full

The safety of sotagliflozin in the therapy of diabetes ...

This meta-analysis showed that the adverse events of sotagliflozin were tolerable to patients with DM, in terms of the incidence of genital mycotic infection.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39485484/

Efficacy and Safety of Sotagliflozin in Patients with Type 1 ...

At week 52, the incidence of severe hypoglycemia was lower with sotagliflozin (7% on 200 mg and 4% on 400 mg) compared with placebo (17%) in the ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02531035

A Phase 3 Study to Evaluate the Safety of Sotagliflozin in ...

This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).