Dose-ranging Study in Patients With Type 1 Diabetes Mellitus
inTandem4
A Phase 2b, Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study in Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
2 other identifiers
interventional
141
1 country
17
Brief Summary
The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2015
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
October 30, 2019
CompletedFebruary 12, 2020
February 1, 2020
1.1 years
May 29, 2015
October 8, 2019
February 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1C (A1C) at Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion \[CSII\] or multiple daily injection \[MDI\]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.
Baseline to Week 12
Secondary Outcomes (5)
Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal
Baseline, Week 12
Absolute Change From Baseline in Body Weight to Week 12
Baseline to Week 12
Percent Change From Baseline in Body Weight to Week 12
Baseline to Week 12
Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion
Baseline, Week 12
Change From Baseline to Week 12 in Fasting Plasma Glucose
Baseline to Week 12
Study Arms (4)
Placebo
PLACEBO COMPARATORTwo placebo-matching sotagliflozin tablets, once daily, orally for 12 weeks.
Sotagliflozin 75 mg
EXPERIMENTALSotagliflozin 75 mg (one 75 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
Sotagliflozin 200 mg
EXPERIMENTALSotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), once daily, orally for 12 weeks.
Sotagliflozin 400 mg
EXPERIMENTALSotagliflozin 400 mg (two 200 mg tablets), once daily, orally for 12 weeks.
Interventions
Placebo, once daily, before the first meal of the day
Sotagliflozin,once daily, before the first meal of the day
Eligibility Criteria
You may qualify if:
- Participant 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 type 1 diabetes mellitus (T1D) made at least 1 year prior to informed consent.
- Participants were being treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injection (MDI).
- At the Screening Visit, A1C had to be between 7.0% and 10.0%.
- Females of childbearing potential had to use an adequate method of contraception and have a negative pregnancy test.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lexicon Pharmaceuticalslead
- Sanoficollaborator
Study Sites (17)
Lexicon Investigational Site
Concord, California, 94520, United States
Lexicon Investigational Site
Ventura, California, 93003, United States
Lexicon Investigational Site
Denver, Colorado, 80209, United States
Lexicon Investigational Site
Jacksonville, Florida, 32225, United States
Lexicon Investigational Site
Miami, Florida, 33175, United States
Lexicon Investigational Site
Springfield, Illinois, 62711, United States
Lexicon Investigational Site
Metairie, Louisiana, 70006, United States
Lexicon Investigational Site
Auburn, Maine, 04210, United States
Lexicon Investigational Site
Rockville, Maryland, 20852, United States
Lexicon Investigational Site
Great Falls, Montana, 59405, United States
Lexicon Investigational Site
Omaha, Nebraska, 68114, United States
Lexicon Investigational Site
High Point, North Carolina, 27265, United States
Lexicon Investigational Site
Columbus, Ohio, 43213, United States
Lexicon Investigational Site
San Antonio, Texas, 78229, United States
Lexicon Investigational Site
Salt Lake City, Utah, 84107, United States
Lexicon Investigational Site
Chesapeake, Virginia, 23321, United States
Lexicon Investigational Site
Manassas, Virginia, 20110, United States
Related Publications (1)
Baker C, Wason S, Banks P, Sawhney S, Chang A, Danne T, Gesty-Palmer D, Kushner JA, McGuire DK, Mikell F, O'Neill M, Peters AL, Strumph P. Dose-dependent glycometabolic effects of sotagliflozin on type 1 diabetes over 12 weeks: The inTandem4 trial. Diabetes Obes Metab. 2019 Nov;21(11):2440-2449. doi: 10.1111/dom.13825. Epub 2019 Aug 1.
PMID: 31264767DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi
Study Officials
- STUDY DIRECTOR
Suman Wason, MD
Lexicon Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2015
First Posted
June 2, 2015
Study Start
July 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
February 12, 2020
Results First Posted
October 30, 2019
Record last verified: 2020-02