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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 ]


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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


  Hide Study Locations
Locations
United States, Alabama
Lexicon Investigational Site
Birmingham, Alabama, United States, 35294
United States, Arkansas
Lexicon Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Lexicon Investigational Site
Escondido, California, United States, 92025
Lexicon Investigational Site
Greenbrae, California, United States, 94904
Lexicon Investigational Site
Huntington Beach, California, United States, 92648
Lexicon Investigational Site
La Jolla, California, United States, 92037
Lexicon Investigational Site
Los Angeles, California, United States, 90057-3550
Lexicon Investigational Site
Orange, California, United States, 92868
Lexicon Investigational Site
Palm Springs, California, United States, 92262
Lexicon Investigational Site
San Mateo, California, United States, 94401
Lexicon Investigational Site
Tarzana, California, United States, 91356
Lexicon Investigational Site
Tustin, California, United States, 92780
Lexicon Investigational Site
Walnut Creek, California, United States, 94598
United States, Colorado
Lexicon Investigational Site
Aurora, Colorado, United States, 70045
Lexicon Investigational Site
Longmont, Colorado, United States, 80501
United States, Florida
Lexicon Investigational Site
Fleming Island, Florida, United States, 32003
Lexicon Investigational Site
Jacksonville, Florida, United States, 32204
Lexicon Investigational Site
Jacksonville, Florida, United States, 32216
Lexicon Investigational Site
New Port Richey, Florida, United States, 34652
Lexicon Investigational Site
Ormond Beach, Florida, United States, 32174
Lexicon Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
Lexicon Investigational Site
Atlanta, Georgia, United States, 30318
Lexicon Investigational Site
Lawrenceville, Georgia, United States, 30046
Lexicon Investigational Site
Roswell, Georgia, United States, 30076
United States, Hawaii
Lexicon Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Illinois
Lexicon Investigational Site
Crystal Lake, Illinois, United States, 60012
Lexicon Investigational Site
Elgin, Illinois, United States, 60123
Lexicon Investigational Site
Springfield, Illinois, United States, 62711
United States, Kansas
Lexicon Investigational Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Lexicon Investigational Site
Lexington, Kentucky, United States, 40503
United States, Maine
Lexicon Investigational Site
Bangor, Maine, United States, 04401
United States, Maryland
Lexicon Investigational Site
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Lexicon Investigational Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Lexicon Investigational Site
Detroit, Michigan, United States, 46214
United States, Missouri
Lexicon Investigational Site
Chesterfield, Missouri, United States, 63017
Lexicon Investigational Site
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Lexicon Investigational Site
Omaha, Nebraska, United States, 68131
United States, Nevada
Lexicon Investigational Site
Henderson, Nevada, United States, 89052
Lexicon Investigational Site
Las Vegas, Nevada, United States, 89148
United States, New York
Lexicon Investigational Site
Albany, New York, United States, 12206
Lexicon Investigational Site
New York, New York, United States, 10029
United States, North Carolina
Lexicon Investigational Site
Asheville, North Carolina, United States, 28803
Lexicon Investigational Site
Chapel Hill, North Carolina, United States, 27517
Lexicon Investigational Site
Morehead City, North Carolina, United States, 28557
United States, Ohio
Lexicon Investigational Site
Columbus, Ohio, United States, 43201
United States, Oklahoma
Lexicon Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Lexicon Investigational Site
Portland, Oregon, United States, 97239
United States, South Carolina
Lexicon Investigational Site
Greer, South Carolina, United States, 29651
United States, South Dakota
Lexicon Investigational Site
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Lexicon Investigational Site
Chattanooga, Tennessee, United States, 37404
Lexicon Investigational Site
Chattanooga, Tennessee, United States, 37411
Lexicon Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Lexicon Investigational Site
Austin, Texas, United States, 78749
Lexicon Investigational Site
Dallas, Texas, United States, 75230
Lexicon Investigational Site
Dallas, Texas, United States, 75231
Lexicon Investigational Site
Dallas, Texas, United States, 75246
Lexicon Investigational Site
Houston, Texas, United States, 77079
Lexicon Investigational Site
Houston, Texas, United States, 77095
Lexicon Investigational Site
San Antonio, Texas, United States, 78258
Lexicon Investigational Site
Schertz, Texas, United States, 78154
United States, Virginia
Lexicon Investigational Site
Chesapeake, Virginia, United States, 23321
United States, Washington
Lexicon Investigational Site
Renton, Washington, United States, 98057
Lexicon Investigational Site
Seattle, Washington, United States, 98105
United States, Wisconsin
Lexicon Investigational Site
Milwaukee, Wisconsin, United States, 53209
Canada, Alberta
Lexicon Investigational Site
Calgary, Alberta, Canada, T2H 2G4
Canada, British Columbia
Lexicon Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Lexicon Investigational Site
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Nova Scotia
Lexicon Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Lexicon Investigational Site
Barrie, Ontario, Canada, L4M 7G1
Lexicon Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
Lexicon Investigational Site
London, Ontario, Canada, N6A 4V2
Lexicon Investigational Site
Ottawa, Ontario, Canada, K1H 7W9
Lexicon Investigational Site
Thornhill, Ontario, Canada, L4J 8L7
Lexicon Investigational Site
Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
Lexicon Investigational Site
Montreal, Quebec, Canada, H2W 1R7
Lexicon Investigational Site
St. Laurent, Quebec, Canada, H4T 1Z9
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