Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus
A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of LX4211 in Patients With Inadequately Controlled Type 1 Diabetes Mellitus
2 other identifiers
interventional
36
1 country
7
Brief Summary
This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2013
Shorter than P25 for phase_2
7 active sites
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
November 20, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
October 30, 2019
CompletedFebruary 12, 2020
February 1, 2020
11 months
November 20, 2012
October 8, 2019
February 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period)
Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100\*(sum \[each daily value - baseline\]/number of assessments)/baseline over Days 3 to 27. Least squares (LS) Means and confidence interval (CI) for the Expansion groups were based on an analysis of covariance (ANCOVA) model with covariates of baseline mean total bolus insulin, treatment group, factor used to stratify the randomization (screening A1C \<= 8%, \> 8%), and random effect of participant\*treatment group. LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean.
Baseline, Day 3 to Day 27
Secondary Outcomes (6)
Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period)
Baseline, Day 3 to Day 27
Percent Change From Baseline in Total Daily Amount of Exogenous Insulin (Total Daily Bolus + Total Daily Basal) Required Calculated Over Days 3 to 27 (Treatment Outpatient Period)
Baseline, Day 3 to Day 27
Change From Baseline in Fasting Plasma Glucose (FPG) at Day 29
Baseline, Day 29
Change From Day 1 in 3-hour Plasma Glucose AUC (AUC0-3 h) Following a Mixed Meal Tolerance Test (MMTT) at Day 29: Expansion Groups
Prior to start of mixed meal and 30, 60, 90, 120 and 180 min post start of mixed meal, on Day 1 and Day 29
Change From Baseline in Percent Time Per Day Spent in Euglycemic Range (>=70 and <=180 mg/dL) Over Days 3 to 27 (Treatment Outpatient Period) Based on Continuous Glucose Monitoring
Baseline, Day 3 to Day 27
- +1 more secondary outcomes
Study Arms (3)
Sotagliflozin 400 mg - Pioneer Group
EXPERIMENTALSotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before breakfast for 29 days; open label administration.
Placebo - Expansion Group
PLACEBO COMPARATORTwo placebo-matching sotagliflozin tablets, once daily, orally, before breakfast for 29 days; double-blind administration.
Sotagliflozin 400 mg - Expansion Group
EXPERIMENTALSotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before breakfast for 29 days; double-blind administration.
Interventions
Participants received sotagliflozin once daily for 29 days. Pioneer Group participants were to have completed dosing prior to any study drug administration in Expansion Groups.
Participants received placebo-matching sotagliflozin tablets once daily for 29 days.
Eligibility Criteria
You may qualify if:
- Adults \>=18 to \<=55 years of age
- Confirmed diagnosis of T1DM, diagnosed prior to age 40 years, and for at least 6 months prior to Screening
- Willing to refrain from using carbohydrate counting to adjust insulin during the study
- Willing and able to wear and operate a continuous glucose monitor
- Willing and able to self-assess blood glucose
- Willing and able to provide written informed consent.
You may not qualify if:
- History of type 2 diabetes mellitus or diabetes resulting from acromegaly, Cushing's disease, chronic pancreatitis, or pancreatectomy
- Two or more severe episodes of hypoglycemia that required emergency treatment within 3 months prior to Screening
- Use of premixed insulin
- History of diabetic ketoacidosis within 1 year of screening
- Presence of active hepatic disease or clinically significant abnormal liver function tests
- History of chronic pancreatitis
- Participants with a history of heart attack, severe/unstable angina, or coronary revascularization procedure
- History of clinically significant cardiac arrhythmias within 1 year prior to screening
- Participants with congestive heart failure
- Participants with uncontrolled Stage III hypertension
- History of human immunodeficiency virus (HIV) or hepatitis C
- History of illicit drug or alcohol abuse within 12 months prior to Screening
- Use of any investigational agent or device within 30 days prior to Screening or any therapeutic protein or antibody within 90 days prior to Screening
- Use of medication or herbal supplements taken for weight loss within 2 weeks of screening
- Chronic use of any antidiabetic therapy other than insulin within 2 months prior to Screening
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lexicon Pharmaceuticalslead
- Sanoficollaborator
Study Sites (7)
Lexicon Investigational Site
Aurora, Colorado, 80045, United States
Lexicon Investigational Site
Atlanta, Georgia, 30318, United States
Lexicon Investigational Site
Baton Rouge, Louisiana, 70808, United States
Lexicon Investigational Site
Omaha, Nebraska, 68131, United States
Lexicon Investigational Site
The Bronx, New York, 10467, United States
Lexicon Investigational Site
Durham, North Carolina, 27713, United States
Lexicon Investigational Site
Dallas, Texas, 75230, United States
Related Publications (1)
Sands AT, Zambrowicz BP, Rosenstock J, Lapuerta P, Bode BW, Garg SK, Buse JB, Banks P, Heptulla R, Rendell M, Cefalu WT, Strumph P. Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes. Diabetes Care. 2015 Jul;38(7):1181-8. doi: 10.2337/dc14-2806. Epub 2015 Jun 6.
PMID: 26049551DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi
Study Officials
- STUDY DIRECTOR
Paul Strumph, M.D.
Lexicon Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2012
First Posted
December 5, 2012
Study Start
February 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
February 12, 2020
Results First Posted
October 30, 2019
Record last verified: 2020-02