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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)

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ClinicalTrials.gov Identifier: NCT02384941
Recruitment Status : Completed
First Posted : March 10, 2015
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
Lexicon Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:
This Phase 3 study is 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 patients with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Sotagliflozin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 793 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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

Experimental: Treatment B
Low dose Sotagliflozin (fasted conditions)
Drug: Sotagliflozin
Low dose Sotagliflozin,once daily, before the first meal of the day

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




Primary Outcome Measures :
  1. Change from baseline of either LX4211 high dose or low dose versus placebo on glycosylated hemoglobin A1C [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in body weight [ Time Frame: 24 weeks ]
  2. Change from baseline in bolus insulin dose [ Time Frame: 24 weeks ]
  3. Change from baseline in fasting plasma glucose [ Time Frame: 24 weeks ]


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
Criteria

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 T1D made at least 1 year prior to informed consent
  • Patients are being treated with insulin or insulin analog delivered via CSII or MDI
  • Willing and able to perform 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 (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 ClinicalTrials.gov identifier (NCT number): NCT02384941


  Show 76 Study Locations
Sponsors and Collaborators
Sanofi
Lexicon Pharmaceuticals
Investigators
Study Director: Sangeeta Sawhney, M.D. Lexicon Pharmaceuticals, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02384941     History of Changes
Other Study ID Numbers: LX4211.1-309-T1DM
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases