CKM For Safe Use of SGLT2i in Type 1 Diabetes

NCT07211802 | Not Yet Recruiting Phase 3 DMC FDA Drug FDA Device

• 3 other identifiers: 8121251R01DK1433811U01DK143381
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being conducted to learn if wearing a combination continuous glucose monitor/continuous ketone monitor (CGM/CKM) can reduce the side effects of taking sotagliflozin (study drug) in people with type 1 diabetes.

Conditions

Type 1 Diabetes (T1D)

Keywords

Sotagliflozin; SGLT2; Continuous Ketone Monitor; DGK; CKM

Outcome Measures

Primary Outcomes (2)

• BHB Time Above 0.6mmol/L - 200mg

  Beta hydroxybutyrate (BHB) time \> 0.6 millimole per liter (mmol/L) as measured by the DGK during the 200mg dosing period in the MDI vs. HCL groups.

  6 weeks

• BHB Time Above 0.6mmol/L - 400mg

  Beta hydroxybutyrate (BHB) time \> 0.6 mmol/L as measured by the DGK during the 400mg dosing period in the MDI vs. HCL groups.

  6 weeks

Secondary Outcomes (1)

• BHB Time Above 0.6mmol/L - 200mg vs. 400mg

  6 weeks

Study Arms (2)

Treatment Group A

EXPERIMENTAL

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

Drug: Sotagliflozin Low Dose; Drug: Sotagliflozin High Dose; Device: Dual Continuous Glucose and Ketone Monitor

Treatment Group B

EXPERIMENTAL

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

Drug: Sotagliflozin Low Dose; Drug: Sotagliflozin High Dose; Device: Dual Continuous Glucose and Ketone Monitor

Interventions

Sotagliflozin Low Dose DRUG

200 mg Sotagliflozin, once daily for 6 weeks

Treatment Group A; Treatment Group B

Sotagliflozin High Dose DRUG

400 mg Sotagliflozin, once daily for 6 weeks

Treatment Group A; Treatment Group B

Dual Continuous Glucose and Ketone Monitor DEVICE

Abbott Libre X dual continuous glucose and ketone monitor (DGK) device.

Treatment Group A; Treatment Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All individuals between the ages of \>18 years old, inclusive, at the time of screening;
• Individuals able to become pregnant must:
• be ≥1 year post-menopausal or documented as being surgically sterile, or
• agree to use two methods of contraception during the entire study and for an additional 2 weeks after the end of dosing with the investigational product;
• Individuals able to cause a pregnancy must be willing to use clinically acceptable method of contraception during the entire study and for an additional 2 weeks after the end of the treatment period;
• Diagnosed with Type 1 diabetes ≥ 1 year prior to screening, based on clinical history or as defined by the current American Diabetes Association (ADA) criteria;
• Treatment with a stable insulin regimen for at least 8 weeks before screening with:
• a continuous subcutaneous insulin infusion (CSII) via a hybrid closed loop system, or
• multiple daily insulin injections;
• Currently using a Continuous Glucose Monitoring (CGM) system;
• Hemoglobin A1c ≤10% at the time of screening;
• Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2;
• Agrees and is able to wear the investigational device;
• Able to provide written informed consent approved by an Institutional Review Board (IRB).

You may not qualify if:

• Individuals who are currently pregnant or lactating/breastfeeding, or planning to become pregnant within 10 months after screening;
• Any concurrent diagnosis of diabetes other than type 1 diabetes;
• 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;
• Hypotension at screening as defined as, systolic blood pressure \< 90 and diastolic blood pressure \< 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations);
• Current or recent (within 1 month prior to screening) use of diabetes medications other than insulin; (examples include, Sodium-Glucose Cotransporter 2 (SGLT-2i), Pramlintide, Metformin);
• Use of glucagon-like-peptide 1 (GLP-1) analogues if not on a stable dose for \> 2 months at screening (participants can be rescreened after being on stable dose for \> 2 months). Participants on a stable dose of GLP-1 receptor antagonist (RA) and not experiencing frequent vomiting may be included.
• Chronic systemic corticosteroids use ( \> 4 consecutive weeks) within 6 months prior to screening;
• History of diabetic ketoacidosis within 3 months prior screening;
• History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening.
• ADA Level 3 Definition - A severe hypoglycemic event characterized by altered mental or physical status requiring the assistance for treatment of hypoglycemia, irrespective of glucose level;
• History of multiple (≥3 infections) genital mycotic infections within 6 months of screening;
• Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits;
• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institutes of Health (NIH): collaborator
• Abbott: collaborator
• Lexicon Pharmaceuticals: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UCSD - Altman Clinical & Translational Research Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Program Manager, MS

CONTACT

858-246-2169; t1dresearch@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: October 8, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)