NCT02383940

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

October 30, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

February 19, 2015

Results QC Date

October 8, 2019

Last Update Submit

February 10, 2020

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Hemoglobin A1C (A1C) at Week 12

    Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Change was calculated by subtracting baseline value from Week 12 value. Least Square (LS) mean changes from baseline were obtained from mixed model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (\<=10%, \>10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.

    Baseline, Week 12

Secondary Outcomes (4)

  • Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12

    Baseline, Week 12

  • Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12

    Baseline, Week 12

  • 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

    Baseline, Week 12

  • Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12

    Baseline, Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks.

Drug: Placebo

Sotagliflozin 400 mg

EXPERIMENTAL

Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.

Drug: Sotagliflozin

Interventions

SotagliflozinDRUG

Sotagliflozin 400 mg, once daily before the first meal of the day

Also known as: LX4211
Sotagliflozin 400 mg
PlaceboDRUG

Placebo, once daily before the first meal of the day

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Lexicon Investigational Site

Tustin, California, 92780, United States

Location

Lexicon Investigational Site

Aurora, Colorado, 80045, United States

Location

Lexicon Investigational Site

New Haven, Connecticut, 06519, United States

Location

Lexicon Investigational Site

Tampa, Florida, 33612, United States

Location

Lexicon Investigational Site

West Palm Beach, Florida, 33401, United States

Location

Lexicon Investigational Site

Atlanta, Georgia, 30318, United States

Location

Lexicon Investigational Site

Roswell, Georgia, 30076, United States

Location

Lexicon Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Lexicon Investigational Site

New Orleans, Louisiana, 70121, United States

Location

Lexicon Investigational Site

Auburn, Maine, 04210, United States

Location

Lexicon Investigational Site

Boston, Massachusetts, 02215, United States

Location

Lexicon Investigational Site

Buffalo, New York, 14222, United States

Location

Lexicon Investigational Site

Wilmington, North Carolina, 28401, United States

Location

Lexicon Investigational Site

Austin, Texas, 78749, United States

Location

Lexicon Investigational Site

Salt Lake City, Utah, 84107, United States

Location

Related Publications (1)

  • 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.

    PMID: 32640846DERIVED

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 MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Trial Transparency Team
Organization
Sanofi
Contact-US@sanofi.com

Study Officials

  • Sangeeta Sawhney, M.D.

    Lexicon Pharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 10, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 12, 2020

Results First Posted

October 30, 2019

Record last verified: 2020-02

Locations

US(15)