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 (inTandem2)

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
782

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Austria
      • Linz, Austria, 4021
        • Lexicon Investigational Site
      • Vienna, Austria, 1010
        • Lexicon Investigational Site
      • Vienna, Austria, 1030
        • Lexicon Investigational Site
      • Vienna, Austria, 1130
        • Lexicon Investigational Site
      • Vienna, Austria, 1160
        • Lexicon Investigational Site
  • Belgium
      • Antwerp, Belgium, 2018
        • Lexicon Investigational Site
      • Brussels, Belgium, 1090
        • Lexicon Investigational Site
      • Edegem, Belgium, 2650
        • Lexicon Investigational Site
      • Leuven, Belgium, 3000
        • Lexicon Investigational Site
      • Sint Niklaas, Belgium, 9100
        • Lexicon Investigational Site
  • Bulgaria
      • Lovech, Bulgaria, 5500
        • Lexicon Investigational Site
      • Plovdiv, Bulgaria, 4002
        • Lexicon Investigational Site
      • Ruse, Bulgaria, 7002
        • Lexicon Investigational Site
      • Smolyan, Bulgaria, 4700
        • Lexicon Investigational Site
      • Sofia, Bulgaria, 1750
        • Lexicon Investigational Site
      • Varna, Bulgaria, 9000
        • Lexicon Investigational Site
  • France
      • Beziers, France, 34500
        • Lexicon Investigational Site
      • Dijon cedex, France, 21079
        • Lexicon Investigational Site
      • Nantes, France, 44000
        • Lexicon Investigational Site
      • Nantes, France, 44093
        • Lexicon Investigational Site
      • Nîmes, France, 30029
        • Lexicon Investigational Site
  • Germany
      • Duesseldorf, Germany, 40210
        • Lexicon Investigational Site
      • Hamburg, Germany, 21073
        • Lexicon Investigational Site
      • Hamburg, Germany, 22607
        • Lexicon Investigational Site
      • Hannover, Germany, 30173
        • Lexicon Investigational Site
      • Mainz, Germany, 55116
        • Lexicon Investigational Site
      • Muenster, Germany, 48145
        • Lexicon Investigational Site
      • Neuwied, Germany, 56564
        • Lexicon Investigational Site
  • Hungary
      • Budapest, Hungary, 1027
        • Lexicon Investigational Site
      • Budapest, Hungary, 1042
        • Lexicon Investigational Site
      • Budapest, Hungary, 1097
        • Lexicon Investigational Site
      • Budapest, Hungary, 1106
        • Lexicon Investigational Site
      • Budapest, Hungary, 1134
        • Lexicon Investigational Site
      • Gyula, Hungary, 5700
        • Lexicon Investigational Site
      • Hodmezovasarhely, Hungary, 6800
        • Lexicon Investigational Site
      • Zalaegerszeg, Hungary, 8900
        • Lexicon Investigational Site
  • Israel
      • Haifa, Israel, 31096
        • Lexicon Investigational Site
      • Holon, Israel, 58100
        • Lexicon Investigational Site
      • Jerusalem, Israel, 91120
        • Lexicon Investigational Site
      • Petah Tikva, Israel, 49202
        • Lexicon Investigational Site
      • Tel Aviv, Israel, 61480
        • Lexicon Investigational Site
      • Tel Hashomer, Israel, 52621
        • Lexicon Investigational Site
      • Zerifin, Israel, 70300
        • Lexicon Investigational Site
  • Italy
      • Catania, Italy, 95123
        • Lexicon Investigational Site
      • Milano, Italy, 20132
        • Lexicon Investigational Site
      • Palermo, Italy, 90127
        • Lexicon Investigational Site
      • Perugia, Italy, 06126
        • Lexicon Investigational Site
      • Pisa, Italy, 56124
        • Lexicon Investigational Site
      • Roma, Italy, 00128
        • Lexicon Investigational Site
  • Lithuania
      • Jonava, Lithuania, LT-55201
        • Lexicon Investigational Site
      • Kaunas, Lithuania, LT-49449
        • Lexicon Investigational Site
      • Kaunas, Lithuania, LT-50161
        • Lexicon Investigational Site
  • Netherlands
      • Dordrecht, Netherlands, 3318
        • Lexicon Investigational Site
  • Poland
      • Katowice, Poland, 40-060
        • Lexicon Investigational Site
      • Kraków, Poland, 30-015
        • Lexicon Investigational Site
      • Lodz, Poland, 90-242
        • Lexicon Investigational Site
      • Lublin, Poland, 20-538
        • Lexicon Investigational Site
      • Poznan, Poland, 61-655
        • Lexicon Investigational Site
      • Szczecin, Poland, 70-506
        • Lexicon Investigational Site
      • Warsaw, Poland, 04-736
        • Lexicon Investigational Site
      • Warszawa, Poland, 02-507
        • Lexicon Investigational Site
      • Warszawa, Poland, 01-518
        • Lexicon Investigational Site
  • Romania
      • Bacau, Romania, 600238
        • Lexicon Investigational Site
      • Bucuresti, Romania, 010507
        • Lexicon Investigational Site
      • Bucuresti, Romania, 013764
        • Lexicon Investigational Site
      • Buzau, Romania, 120203
        • Lexicon Investigational Site
      • Galati, Romania, 800098
        • Lexicon Investigational Site
      • Oradea, Romania, 410159
        • Lexicon Investigational Site
      • Sibiu, Romania, 550371
        • Lexicon Investigational Site
      • Targu-Mures, Romania, 540142
        • Lexicon Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • Lexicon Investigational Site
      • Bratislava, Slovakia, 821 02
        • Lexicon Investigational Site
      • Kosice, Slovakia, 040 01
        • Lexicon Investigational Site
      • Nove Zamky, Slovakia, 940 01
        • Lexicon Investigational Site
      • Sturovo, Slovakia, 943 01
        • Lexicon Investigational Site
      • Vrutky, Slovakia, 038 61
        • Lexicon Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • Lexicon Investigational Site
      • Barcelona, Spain, 08036
        • Lexicon Investigational Site
      • Granada, Spain, 18012
        • Lexicon Investigational Site
      • Malaga, Spain, 29006
        • Lexicon Investigational Site
      • Sevilla, Spain, 41009
        • Lexicon Investigational Site
      • Sevilla, Spain, 41003
        • Lexicon Investigational Site
      • Sevilla, Spain, 41010
        • Lexicon Investigational Site
      • Sevilla, Spain, 41014
        • Lexicon Investigational Site
      • Valencia, Spain, 46014
        • Lexicon Investigational Site
  • Sweden
      • Härnösand, Sweden, 871 82
        • Lexicon Investigational Site
      • Kristianstad, Sweden, 291 85
        • Lexicon Investigational Site
      • Stockholm, Sweden, 112 21
        • Lexicon Investigational Site
  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Lexicon Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Lexicon Investigational Site
      • Blackburn, United Kingdom, BB2 3HH
        • Lexicon Investigational Site
      • Bristol, United Kingdom, BS10 5NB
        • Lexicon Investigational Site
      • Glasgow, United Kingdom, G4 0SF
        • Lexicon Investigational Site
      • Leeds, United Kingdom, LS2 9JT
        • Lexicon Investigational Site
      • Leicester, United Kingdom, LE5 4PW
        • Lexicon Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant who gave 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 treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
  • Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol.
  • At the Screening Visit, A1C was 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 screening.
  • Chronic systemic corticosteroid use.
  • Type 2 diabetes mellitus (T2DM), 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: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
Drug: Placebo
Placebo, once daily, before the first meal of the day
EXPERIMENTAL: Sotagliflozin 200 mg
Sotagliflozin 200 milligram (mg) (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
Drug: Sotagliflozin
High dose Sotagliflozin, once daily, before the first meal of the day
Drug: Sotagliflozin
Low dose Sotagliflozin,once daily, before the first meal of the day
EXPERIMENTAL: Sotagliflozin 400 mg
Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
Drug: Sotagliflozin
High dose Sotagliflozin, once daily, before the first meal of the day
Drug: Sotagliflozin
Low dose Sotagliflozin,once daily, before the first meal of the day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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 reduction of A1C value at Week 24) indicates an improvement.
Baseline to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24
Time Frame: Baseline to Week 24
The composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value <7.0% and a central blinded adjudication process to determine 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
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/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 and a positive change from baseline indicated an increase 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 level at Week 24 compared to baseline and a positive change from baseline indicates an increase in glucose level at Week 24 compared to baseline.
Baseline to Week 24
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24
Time Frame: Baseline to Week 24
The DTSQ instrument contains 8 items assessing overall treatment satisfaction, treatment convenience and flexibility, satisfaction with understanding of diabetes, willingness to continue present treatment and to recommend it to others, and frequency of unacceptably high and unacceptably low blood glucose levels. 6 items (1, 4, 5, 6, 7 and 8) (excluding perceived hyperglycemia and hypoglycemia items) were scored using a 7- point scale where 0=very dissatisfied to 6= very satisfied for a total possible score of 0 (very dissatisfied) to 36 (very satisfied), where higher scores indicate higher satisfaction from treatment. Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively. 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 positive change from baseline indicates improvement.
Baseline to Week 24
Change From Baseline in 2-Item Diabetes Distress Screen 2 (DDS2) Score at Week 24
Time Frame: Baseline to Week 24
DDS2 is a 2-item diabetes distress screening instrument where participants rated 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 to 12. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates improvement.
Baseline to Week 24

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lexicon Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 23, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LX4211.1-310-T1DM
  • LX4211.310 (OTHER: Lexicon Pharmaceuticals)
  • 2014-005153-39 (EUDRACT_NUMBER)

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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