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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

February 23, 2015
March 10, 2015
December 26, 2017
March 2015
September 2016   (Final data collection date for primary outcome measure)
Change from baseline of either LX4211 high dose or low dose versus placebo on glycosylated hemoglobin A1C [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT02384941 on ClinicalTrials.gov Archive Site
  • Change from baseline in body weight [ Time Frame: 24 weeks ]
  • Change from baseline in bolus insulin dose [ Time Frame: 24 weeks ]
  • Change from baseline in fasting plasma glucose [ Time Frame: 24 weeks ]
Same as current
Not Provided
Not Provided
 
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, 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 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • Drug: Sotagliflozin
    High dose Sotagliflozin, once daily, before the first meal of the day
  • Drug: Sotagliflozin
    Low dose Sotagliflozin,once daily, before the first meal of the day
  • Drug: Placebo
    Placebo, once daily, before the first meal of the day
  • Experimental: Treatment A
    High dose Sotagliflozin (fasted conditions)
    Intervention: Drug: Sotagliflozin
  • Experimental: Treatment B
    Low dose Sotagliflozin (fasted conditions)
    Intervention: Drug: Sotagliflozin
  • Placebo Comparator: Treatment C
    Placebo (fasted conditions)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
793
750
February 2017
September 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT02384941
LX4211.1-309-T1DM
Yes
Not Provided
Not Provided
Sanofi
Sanofi
Lexicon Pharmaceuticals
Study Director: Sangeeta Sawhney, M.D. Lexicon Pharmaceuticals, Inc.
Sanofi
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP