Clinical trial NCT02383940: Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of LX4211 in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Juvenile Diabetes Research Foundation
name: Sanofi
First posted: 2015-03-10
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.


Eligibility criteria: Inclusion Criteria:

* Participant had given written informed consent.
* Young adult participants \>=18 to \<=30 years old at Screening, with a confirmed diagnosis of T1DM made at least 1 year prior to informed consent.
* Participants were being treated with insulin or insulin analogue delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
* At Screening, must had A1C \>= 9.0%.
* Must be willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary.
* Females of childbearing potential must use an adequate method of contraception and had a negative pregnancy test.

Exclusion Criteria:

* Any prior use of LX4211/sotagliflozin.
* Use of antidiabetic agent other than insulin or insulin analogue at the time of screening.
* Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to start of the placebo Run-in Period.
* Chronic systemic corticosteroid use.
* Type 2 diabetes, or severely uncontrolled diabetes mellitus as determined by the Investigator.
* History of diabetic ketoacidosis (DKA) or nonketotic hyperosmolar state within 6 months prior to the Screening Visit.
* History of severe hypoglycemic event within 1 month prior to the Screening Visit.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1C (A1C) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Lexicon Investigational Site
state: California
city: Aurora
country: United States
facility: Lexicon Investigational Site
state: Colorado
city: New Haven
country: United States
facility: Lexicon Investigational Site
state: Connecticut
city: Tampa
country: United States
facility: Lexicon Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Lexicon Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Lexicon Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Lexicon Investigational Site
state: Georgia
city: Indianapolis
country: United States
facility: Lexicon Investigational Site
state: Indiana
city: New Orleans
country: United States
facility: Lexicon Investigational Site
state: Louisiana
city: Auburn
country: United States
facility: Lexicon Investigational Site
state: Maine
city: Boston
country: United States
facility: Lexicon Investigational Site
state: Massachusetts
city: Buffalo
country: United States
facility: Lexicon Investigational Site
state: New York
city: Wilmington
country: United States
facility: Lexicon Investigational Site
state: North Carolina
city: Austin
country: United States
facility: Lexicon Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Lexicon Investigational Site
state: Utah
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Sangeeta Sawhney, M.D.
role: STUDY_DIRECTOR
References:
citation: Bode BW, Cengiz E, Wadwa RP, Banks P, Danne T, Kushner JA, McGuire DK, Peters AL, Strumph P, Sawhney S. Effects of Sotagliflozin Combined with Intensive Insulin Therapy in Young Adults with Poorly Controlled Type 1 Diabetes: The JDRF Sotagliflozin Study. Diabetes Technol Ther. 2021 Jan;23(1):59-69. doi: 10.1089/dia.2020.0079.