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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. Identifier: NCT02531035
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : December 26, 2017
Lexicon Pharmaceuticals
Information provided by (Responsible Party):

Brief Summary:
This Phase 3 study is designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with 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

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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
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

Arm Intervention/treatment
Experimental: Treatment A
Sotagliflozin (fasted conditions)
Drug: Sotagliflozin
Sotagliflozin, once daily, before the first meal of the day
Other Name: LX4211

Placebo Comparator: Treatment B
Placebo (fasted conditions)
Drug: Placebo
Placebo, once daily, before the first meal of the day

Primary Outcome Measures :
  1. Proportion of patients with A1C <7.0% at Week 24 and no episode of severe hypoglycemia and no episode of DKA after randomization [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 24 in A1C [ Time Frame: Week 24 ]
  2. Change from Baseline in body weight [ Time Frame: Week 24 ]
  3. Change from Baseline in systolic blood pressure (SBP) [ Time Frame: Week 16 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patient has given written informed consent to participate in the study in accordance with local regulations
  • Adult patients 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent
  • Patients are 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 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 screening
  • Chronic systemic corticosteroid use
  • Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator

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 identifier (NCT number): NCT02531035

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Sponsors and Collaborators
Lexicon Pharmaceuticals
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Study Director: Sangeeta Sawhney, MD Lexicon Pharmaceuticals, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanofi Identifier: NCT02531035     History of Changes
Other Study ID Numbers: LX4211.1-312-T1DM
LX4211.312 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
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
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action