Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy (inTandem1)

February 10, 2020 updated by: Lexicon Pharmaceuticals

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

793

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 2G4
        • Lexicon Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Lexicon Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Lexicon Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Lexicon Investigational Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Lexicon Investigational Site
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Lexicon Investigational Site
      • London, Ontario, Canada, N6A 4V2
        • Lexicon Investigational Site
      • Ottawa, Ontario, Canada, K1H 7W9
        • Lexicon Investigational Site
      • Thornhill, Ontario, Canada, L4J 8L7
        • Lexicon Investigational Site
      • Toronto, Ontario, Canada, M4G 3E8
        • Lexicon Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Lexicon Investigational Site
      • St. Laurent, Quebec, Canada, H4T 1Z9
        • Lexicon Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Lexicon Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Lexicon Investigational Site
    • California
      • Escondido, California, United States, 92025
        • Lexicon Investigational Site
      • Greenbrae, California, United States, 94904
        • Lexicon Investigational Site
      • Huntington Beach, California, United States, 92648
        • Lexicon Investigational Site
      • La Jolla, California, United States, 92037
        • Lexicon Investigational Site
      • Los Angeles, California, United States, 90057-3550
        • Lexicon Investigational Site
      • Orange, California, United States, 92868
        • Lexicon Investigational Site
      • Palm Springs, California, United States, 92262
        • Lexicon Investigational Site
      • San Mateo, California, United States, 94401
        • Lexicon Investigational Site
      • Tarzana, California, United States, 91356
        • Lexicon Investigational Site
      • Tustin, California, United States, 92780
        • Lexicon Investigational Site
      • Walnut Creek, California, United States, 94598
        • Lexicon Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 70045
        • Lexicon Investigational Site
      • Longmont, Colorado, United States, 80501
        • Lexicon Investigational Site
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Lexicon Investigational Site
      • Jacksonville, Florida, United States, 32204
        • Lexicon Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Lexicon Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Lexicon Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • Lexicon Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Lexicon Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Lexicon Investigational Site
      • Lawrenceville, Georgia, United States, 30046
        • Lexicon Investigational Site
      • Roswell, Georgia, United States, 30076
        • Lexicon Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Lexicon Investigational Site
    • Illinois
      • Crystal Lake, Illinois, United States, 60012
        • Lexicon Investigational Site
      • Elgin, Illinois, United States, 60123
        • Lexicon Investigational Site
      • Springfield, Illinois, United States, 62711
        • Lexicon Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Lexicon Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Lexicon Investigational Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Lexicon Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Lexicon Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Lexicon Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 46214
        • Lexicon Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Lexicon Investigational Site
      • Saint Louis, Missouri, United States, 63110
        • Lexicon Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Lexicon Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Lexicon Investigational Site
      • Las Vegas, Nevada, United States, 89148
        • Lexicon Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Lexicon Investigational Site
      • New York, New York, United States, 10029
        • Lexicon Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Lexicon Investigational Site
      • Chapel Hill, North Carolina, United States, 27517
        • Lexicon Investigational Site
      • Morehead City, North Carolina, United States, 28557
        • Lexicon Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43201
        • Lexicon Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lexicon Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Lexicon Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Lexicon Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Lexicon Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Lexicon Investigational Site
      • Chattanooga, Tennessee, United States, 37411
        • Lexicon Investigational Site
      • Memphis, Tennessee, United States, 38119
        • Lexicon Investigational Site
    • Texas
      • Austin, Texas, United States, 78749
        • Lexicon Investigational Site
      • Dallas, Texas, United States, 75230
        • Lexicon Investigational Site
      • Dallas, Texas, United States, 75231
        • Lexicon Investigational Site
      • Dallas, Texas, United States, 75246
        • Lexicon Investigational Site
      • Houston, Texas, United States, 77079
        • Lexicon Investigational Site
      • Houston, Texas, United States, 77095
        • Lexicon Investigational Site
      • San Antonio, Texas, United States, 78258
        • Lexicon Investigational Site
      • Schertz, Texas, United States, 78154
        • Lexicon Investigational Site
    • Virginia
      • Chesapeake, Virginia, United States, 23321
        • Lexicon Investigational Site
    • Washington
      • Renton, Washington, United States, 98057
        • Lexicon Investigational Site
      • Seattle, Washington, United States, 98105
        • Lexicon Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants had given written informed consent to participate in the study in accordance with local regulations.
  • Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent.
  • Participants were being treated with insulin or insulin analog delivered. via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
  • Willing and able to perform self-monitored blood glucose (SMBG) and complete the study diary as required per protocol.
  • At the Screening Visit, A1C must be between 7.0% to 11.0%.
  • Females of childbearing potential must use an adequate method of contraception and have a negative pregnancy test .

Exclusion Criteria:

  • Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
  • Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to randomization.
  • Chronic systemic corticosteroid use.
  • Type 2 diabetes mellitus (T2D), or severely uncontrolled T1D as determined by the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Two placebo-matching sotagliflozin tables, orally for 24 weeks followed by a 28 week extension period.
Drug: Placebo
Placebo once daily, before first meal of the day.
EXPERIMENTAL: Sotagliflozin 200 milligrams (mg)
Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), orally, for 24 weeks followed by a 28 week extension period.
Drug: Placebo
Placebo once daily, before first meal of the day.
Drug: Sotagliflozin
Sotagliflozin once daily, before first meal of the day.
Other Names:
  • LX4211
EXPERIMENTAL: Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), orally, for 24 weeks followed by a 28 week extension period.
Drug: Sotagliflozin
Sotagliflozin once daily, before first meal of the day.
Other Names:
  • LX4211

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in A1C at Week 24
Time Frame: Baseline to Week 24
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (<= 8.5%, >8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from Baseline (a lower A1C value at Week 24) indicates an improvement.
Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With A1C <7.0% (at Week 24) and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) Upto Week 24
Time Frame: Baseline to Week 24
Blood samples were collected for the assessment of Hemoglobin A1C to determine the participants with A1C value <7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.
Baseline to Week 24
Absolute Change From Baseline in Body Weight at Week 24
Time Frame: Baseline to Week 24
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from Baseline indicates a loss in body weight from Baseline to Week 24.
Baseline to Week 24
Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24
Time Frame: Baseline to Week 24
The mean bolus insulin dose in international units per day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post Baseline values. A negative change from Baseline indicated a reduction in the amount of bolus insulin used between Baseline and Week 24.
Baseline to Week 24
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time Frame: Baseline to Week 24
The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates a lower glucose at Week 24 compared to baseline.
Baseline to Week 24
Change From Baseline in Diabetes Total Treatment Satisfaction Scores as Measured by Total Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Scores at Week 24
Time Frame: Baseline to Week 24
DTSQs is a diabetes-specific measure used to evaluate overall treatment satisfaction and perception of hyperglycemia and hypoglycemia events. It consists of 8 items and the response categories for all items were on a 7-point likert scale.The DTSQs response options ranged from 0 (very dissatisfied) to 6 (very satisfied). Responses to item 1, 4, 5, 6, 7 and 8 were summarized to determine the total treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied), with a higher score corresponding to higher satisfaction . LS means were obtained from MMRM model including all available post baseline values. A positive change from baseline indicates improvement.
Baseline to Week 24
Change From Baseline in Diabetes Distress Scores as Measured by 2-item Diabetes Distress Screening Scale (DDS2) Scores at Week 24
Time Frame: Baseline to Week 24
The DDS2 is a 2-item diabetes distress screening instrument where respondents rated, on a 6-point scale, the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen using a 6-point scale: where 1=no distress to 6=severe distress for a total possible score of 2 (not a problem) to 12 (very serious problem), with higher score corresponding to higher distress. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates improvement.
Baseline to Week 24
Percent Change From Baseline in Body Weight at Week 24
Time Frame: Baseline to Week 24
Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative percent change from baseline indicates a loss in body weight from baseline to Week 24.
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lexicon Pharmaceuticals

Collaborators

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2015

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (ESTIMATE)

March 10, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LX4211.1-309-T1DM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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