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Type 1 Diabetes MellitusPhase 3inTandem1NCT02384941

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

A Phase 3 study testing Sotagliflozin in people with Type 1 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 75 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Sotagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
793 participants
Where
75 sitesin 2 countries
Study dates
Mar 2015to Feb 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 .

Who cannot join

  • 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.

Trial locations and contacts

75 sites in 2 countries.

75 sites in 2 countries

United States63 sites

  • Lexicon Investigational Site

    Albany, New York, 12206

  • Lexicon Investigational Site

    Asheville, North Carolina, 28803

  • Lexicon Investigational Site

    Atlanta, Georgia, 30318

  • Lexicon Investigational Site

    Aurora, Colorado, 70045

  • Lexicon Investigational Site

    Austin, Texas, 78749

  • Lexicon Investigational Site

    Baltimore, Maryland, 21204

  • Lexicon Investigational Site

    Bangor, Maine, 04401

  • Lexicon Investigational Site

    Birmingham, Alabama, 35294

  • Lexicon Investigational Site

    Boston, Massachusetts, 02215

  • Lexicon Investigational Site

    Chapel Hill, North Carolina, 27517

  • Lexicon Investigational Site

    Chattanooga, Tennessee, 37404

  • Lexicon Investigational Site

    Chattanooga, Tennessee, 37411

  • Lexicon Investigational Site

    Chesapeake, Virginia, 23321

  • Lexicon Investigational Site

    Chesterfield, Missouri, 63017

  • Lexicon Investigational Site

    Columbus, Ohio, 43201

  • Lexicon Investigational Site

    Crystal Lake, Illinois, 60012

  • Lexicon Investigational Site

    Dallas, Texas, 75230

  • Lexicon Investigational Site

    Dallas, Texas, 75231

  • Lexicon Investigational Site

    Dallas, Texas, 75246

  • Lexicon Investigational Site

    Detroit, Michigan, 46214

  • Lexicon Investigational Site

    Elgin, Illinois, 60123

  • Lexicon Investigational Site

    Escondido, California, 92025

  • Lexicon Investigational Site

    Fleming Island, Florida, 32003

  • Lexicon Investigational Site

    Greenbrae, California, 94904

  • Lexicon Investigational Site

    Greer, South Carolina, 29651

  • Lexicon Investigational Site

    Henderson, Nevada, 89052

  • Lexicon Investigational Site

    Honolulu, Hawaii, 96814

  • Lexicon Investigational Site

    Houston, Texas, 77079

  • Lexicon Investigational Site

    Houston, Texas, 77095

  • Lexicon Investigational Site

    Huntington Beach, California, 92648

  • Lexicon Investigational Site

    Jacksonville, Florida, 32204

  • Lexicon Investigational Site

    Jacksonville, Florida, 32216

  • Lexicon Investigational Site

    La Jolla, California, 92037

  • Lexicon Investigational Site

    Las Vegas, Nevada, 89148

  • Lexicon Investigational Site

    Lawrenceville, Georgia, 30046

  • Lexicon Investigational Site

    Lexington, Kentucky, 40503

  • Lexicon Investigational Site

    Little Rock, Arkansas, 72205

  • Lexicon Investigational Site

    Longmont, Colorado, 80501

  • Lexicon Investigational Site

    Los Angeles, California, 90057-3550

  • Lexicon Investigational Site

    Memphis, Tennessee, 38119

  • Lexicon Investigational Site

    Morehead City, North Carolina, 28557

  • Lexicon Investigational Site

    New Port Richey, Florida, 34652

  • Lexicon Investigational Site

    New York, New York, 10029

  • Lexicon Investigational Site

    Oklahoma City, Oklahoma, 73112

  • Lexicon Investigational Site

    Omaha, Nebraska, 68131

  • Lexicon Investigational Site

    Orange, California, 92868

  • Lexicon Investigational Site

    Ormond Beach, Florida, 32174

  • Lexicon Investigational Site

    Palm Springs, California, 92262

  • Lexicon Investigational Site

    Portland, Oregon, 97239

  • Lexicon Investigational Site

    Rapid City, South Dakota, 57701

  • Lexicon Investigational Site

    Renton, Washington, 98057

  • Lexicon Investigational Site

    Roswell, Georgia, 30076

  • Lexicon Investigational Site

    San Antonio, Texas, 78258

  • Lexicon Investigational Site

    San Mateo, California, 94401

  • Lexicon Investigational Site

    Schertz, Texas, 78154

  • Lexicon Investigational Site

    Seattle, Washington, 98105

  • Lexicon Investigational Site

    Springfield, Illinois, 62711

  • Lexicon Investigational Site

    St Louis, Missouri, 63110

  • Lexicon Investigational Site

    Tarzana, California, 91356

  • Lexicon Investigational Site

    Topeka, Kansas, 66606

  • Lexicon Investigational Site

    Tustin, California, 92780

  • Lexicon Investigational Site

    Walnut Creek, California, 94598

  • Lexicon Investigational Site

    West Palm Beach, Florida, 33401

Other trials in United States

Canada12 sites

  • Lexicon Investigational Site

    Barrie, Ontario, L4M 7G1

  • Lexicon Investigational Site

    Calgary, Alberta, T2H 2G4

  • Lexicon Investigational Site

    Halifax, Nova Scotia, B3H 1V7

  • Lexicon Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • Lexicon Investigational Site

    London, Ontario, N6A 4V2

  • Lexicon Investigational Site

    Montreal, Quebec, H2W 1R7

  • Lexicon Investigational Site

    Ottawa, Ontario, K1H 7W9

  • Lexicon Investigational Site

    Saint-Laurent, Quebec, H4T 1Z9

  • Lexicon Investigational Site

    Thornhill, Ontario, L4J 8L7

  • Lexicon Investigational Site

    Toronto, Ontario, M4G 3E8

  • Lexicon Investigational Site

    Vancouver, British Columbia, V5Z 1M9

  • Lexicon Investigational Site

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

About this study

Official title: 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.

Being tested
Placebo, Sotagliflozin
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo once daily, before first meal of the day.

  • SotagliflozinDrug

    Also called LX4211

    Sotagliflozin once daily, before first meal of the day.

Study groups in NCT02384941
Study groupRoleWhat they receive
PlaceboPlacebo comparatorTwo placebo-matching sotagliflozin tables, orally for 24 weeks followed by a 28 week extension period.
Receives: Drug: Placebo
Sotagliflozin 200 milligrams (mg)ExperimentalSotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), orally, for 24 weeks followed by a 28 week extension period.
Receives: Drug: Placebo; Drug: Sotagliflozin
Sotagliflozin 400 mgExperimentalSotagliflozin 400 mg (two 200 mg tablets), orally, for 24 weeks followed by a 28 week extension period.
Receives: Drug: Sotagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in A1C at 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.

    Measured: Baseline to Week 24

Secondary outcomes (7)

  1. 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

    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.

    Measured: Baseline to Week 24

  2. Absolute Change From Baseline in Body Weight at 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.

    Measured: Baseline to Week 24

  3. Change From Baseline in Mean Daily Bolus Insulin Dose at 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.

    Measured: Baseline to Week 24

  4. Change From Baseline in Fasting Plasma Glucose (FPG) at 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.

    Measured: Baseline to Week 24

  5. Change From Baseline in Diabetes Total Treatment Satisfaction Scores as Measured by Total Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Scores at 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.

    Measured: Baseline to Week 24

  6. Change From Baseline in Diabetes Distress Scores as Measured by 2-item Diabetes Distress Screening Scale (DDS2) Scores at 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.

    Measured: Baseline to Week 24

  7. Percent Change From Baseline in Body Weight at 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.

    Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionSep 2016
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
793 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02384941
Sponsor's protocol ID
LX4211.1-309-T1DM
Acronym
inTandem1
Status last verified
Feb 2020
First submitted
23 Feb 2015
Last updated
12 Feb 2020
Data monitoring committee
Yes

Publications

  • Peters AL, McGuire DK, Danne T, Kushner JA, Rodbard HW, Dhatariya K, Sawhney S, Banks P, Jiang W, Davies MJ, Lapuerta P. Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies. Diabetes Care. 2020 Nov;43(11):2713-2720. doi: 10.2337/dc20-0924. Epub 2020 Sep 14.

    PubMed 32928957

  • Danne T, Joish VN, Afonso M, Banks P, Sawhney S, Lapuerta P, Davies MJ, Buse JB, Lin D, Reaney M, Guillonneau S, Snoek FJ, Bailey TS, Polonsky WH. Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone. Diabetes Technol Ther. 2021 Jan;23(1):70-77. doi: 10.1089/dia.2020.0068.

    PubMed 32721228

  • Ervin C, Joish VN, Evans E, DiBenedetti D, Reaney M, Preblick R, Castro R, Danne T, Buse JB, Lapuerta P. Insights Into Patients' Experience With Type 1 Diabetes: Exit Interviews From Phase III Studies of Sotagliflozin. Clin Ther. 2019 Nov;41(11):2219-2230.e6. doi: 10.1016/j.clinthera.2019.09.003. Epub 2019 Oct 3.

    PubMed 31587812

  • Danne T, Cariou B, Buse JB, Garg SK, Rosenstock J, Banks P, Kushner JA, McGuire DK, Peters AL, Sawhney S, Strumph P. Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program. Diabetes Care. 2019 May;42(5):919-930. doi: 10.2337/dc18-2149. Epub 2019 Mar 4.

    PubMed 30833371

  • Buse JB, Garg SK, Rosenstock J, Bailey TS, Banks P, Bode BW, Danne T, Kushner JA, Lane WS, Lapuerta P, McGuire DK, Peters AL, Reed J, Sawhney S, Strumph P. Sotagliflozin in Combination With Optimized Insulin Therapy in Adults With Type 1 Diabetes: The North American inTandem1 Study. Diabetes Care. 2018 Sep;41(9):1970-1980. doi: 10.2337/dc18-0343. Epub 2018 Jun 24.

    PubMed 29937430

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sotagliflozin in people with Type 1 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 75 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in A1C at Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02384941, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.

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