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A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone (inTandem3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02531035
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : November 19, 2019
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Study Description
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Brief Summary:
This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus (T1DM) High Level of Sugar (Glucose) in the Blood Drug: Sotagliflozin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes
Actual Study Start Date : September 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 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 24 weeks.
 Drug: Sotagliflozin
Sotagliflozin, once daily, before the first meal of the day
Other Name: LX4211


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization [ Time Frame: Week 24 ]
    The primary composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value <7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia.


Secondary Outcome Measures :
  1. Change From Baseline in A1C [ 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 Squares (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) model including all available post baseline data. A negative change from Baseline (a lower AIC value at Week 24) indicates an improvement.

  2. Absolute Change From Baseline in Body Weight [ 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.

  3. Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg) [ Time Frame: Baseline to Week 16 ]
    An automatic sphygmomanometer was used with instructions on blood pressure measurements to allow for standardization. Week 16 was used because the protocol required Investigators to keep participant's hypertensive medications stable between Baseline and Week 16, unless a change was required for safety reasons. Baseline was defined as the last value collected prior to the first does of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change indicates a decrease in SBP between Baseline and Week 16.

  4. Percent Change From Baseline in Mean Daily Bolus Insulin Dose [ 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 percent change from Baseline indicated a reduction in the amount of bolus insulin used and a positive percent change from Baseline indicated an increase in the amount of bolus insulin used between Baseline and Week 24.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 T1DM made at least 1 year prior to informed consent
  • Participants were being treated with insulin or insulin analog
  • Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
  • At the Screening Visit, A1C was between 7.0% to 11.0%
  • Females of childbearing potential used an adequate method of contraception and had 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
Contacts and Locations
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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): NCT02531035


Locations
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Sponsors and Collaborators
Lexicon Pharmaceuticals
Sanofi
Investigators
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Study Director: Sangeeta Sawhney, MD Lexicon Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Lexicon Pharmaceuticals:
Study Protocol  [PDF] October 16, 2015
Statistical Analysis Plan  [PDF] March 29, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02531035    
Other Study ID Numbers: LX4211.1-312-T1DM
LX4211.312 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: August 21, 2015    Key Record Dates
Results First Posted: November 19, 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