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Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

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ClinicalTrials.gov Identifier: NCT02383940
Recruitment Status : Completed
First Posted : March 10, 2015
Results First Posted : October 30, 2019
Last Update Posted : February 12, 2020
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Sotagliflozin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks.
Drug: Placebo
Placebo, once daily before the first meal of the day

Experimental: Sotagliflozin 400 mg
Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.
Drug: Sotagliflozin
Sotagliflozin 400 mg, once daily before the first meal of the day
Other Name: LX4211




Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin A1C (A1C) at Week 12 [ Time Frame: Baseline, 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.


Secondary Outcome Measures :
  1. Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12 [ Time Frame: Baseline, Week 12 ]
    The daily bolus and basal insulin doses were calculated as an average of the doses over 3 to 5 days before each visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.

  2. Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12 [ Time Frame: Baseline, Week 12 ]
    A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. At Week 12, study drug was to be given within 15 minutes before liquid "Boost®," "Ensure®," or similar nutrition drink product; at baseline, study drug was to be given after the 2-hour post-Mixed Meal PPG sample. Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from analysis of covariance (ANCOVA) model.

  3. 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 [ Time Frame: Baseline, Week 12 ]
    Glycemic instability (mg/dL*minutes/1000) by hyperglycemia/hypoglycemia was measured by CGM AUC outside target range (as a daily average over the week prior to the visit [Baseline and Week 12]) over 24 hours, where outside target range was defined as CGM glucose AUC >150 mg/dL (hyperglycemia) and CGM glucose AUC <70 mg/dL (hypoglycemia). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.

  4. Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12 [ Time Frame: Baseline, Week 12 ]
    Hypoglycemic event by SMBG was defined as an event in which the fingerstick measurement was <=70 mg/dL. The number of hypoglycemic events per day was calculated as a daily average number of episodes over the week prior to visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383940


Locations
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United States, California
Lexicon Investigational Site
Tustin, California, United States, 92780
United States, Colorado
Lexicon Investigational Site
Aurora, Colorado, United States, 80045
United States, Connecticut
Lexicon Investigational Site
New Haven, Connecticut, United States, 06519
United States, Florida
Lexicon Investigational Site
Tampa, Florida, United States, 33612
Lexicon Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Lexicon Investigational Site
Atlanta, Georgia, United States, 30318
Lexicon Investigational Site
Roswell, Georgia, United States, 30076
United States, Indiana
Lexicon Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Lexicon Investigational Site
New Orleans, Louisiana, United States, 70121
United States, Maine
Lexicon Investigational Site
Auburn, Maine, United States, 04210
United States, Massachusetts
Lexicon Investigational Site
Boston, Massachusetts, United States, 02215
United States, New York
Lexicon Investigational Site
Buffalo, New York, United States, 14222
United States, North Carolina
Lexicon Investigational Site
Wilmington, North Carolina, United States, 28401
United States, Texas
Lexicon Investigational Site
Austin, Texas, United States, 78749
United States, Utah
Lexicon Investigational Site
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Lexicon Pharmaceuticals
Juvenile Diabetes Research Foundation
Sanofi
Investigators
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Study Director: Sangeeta Sawhney, M.D. Lexicon Pharmaceuticals, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02383940    
Other Study ID Numbers: LX4211.1-204-T1DM
LX4211.204 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: March 10, 2015    Key Record Dates
Results First Posted: October 30, 2019
Last Update Posted: February 12, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs