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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02531035
Registration number
NCT02531035
Ethics application status
Date submitted
20/08/2015
Date registered
21/08/2015
Date last updated
12/02/2020
Titles & IDs
Public title
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
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Scientific 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
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Secondary ID [1]
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LX4211.312
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Secondary ID [2]
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LX4211.1-312-T1DM
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Universal Trial Number (UTN)
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Trial acronym
inTandem3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus (T1DM)
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High Level of Sugar (Glucose) in the Blood
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Sotagliflozin
Treatment: Drugs - Placebo
Placebo Comparator: Placebo - Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
Experimental: Sotagliflozin 400 mg - Sotagliflozin 400 milligram (mg) (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.
Treatment: Drugs: Sotagliflozin
Sotagliflozin, once daily, before the first meal of the day
Treatment: Drugs: Placebo
Placebo, once daily, before the first meal of the day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization
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Assessment method [1]
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The primary composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value <7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia.
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Change From Baseline in A1C
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Assessment method [1]
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Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least Squares (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) model including all available post baseline data. A negative change from Baseline (a lower AIC value at Week 24) indicates an improvement.
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Timepoint [1]
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Baseline to Week 24
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Secondary outcome [2]
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Absolute Change From Baseline in Body Weight
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Assessment method [2]
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Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from Baseline indicates a loss in body weight from Baseline to Week 24.
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Timepoint [2]
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Baseline to Week 24
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Secondary outcome [3]
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Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg)
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Assessment method [3]
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An automatic sphygmomanometer was used with instructions on blood pressure measurements to allow for standardization. Week 16 was used because the protocol required Investigators to keep participant's hypertensive medications stable between Baseline and Week 16, unless a change was required for safety reasons. Baseline was defined as the last value collected prior to the first does of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change indicates a decrease in SBP between Baseline and Week 16.
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Timepoint [3]
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Baseline to Week 16
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Secondary outcome [4]
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Percent Change From Baseline in Mean Daily Bolus Insulin Dose
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Assessment method [4]
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The mean bolus insulin dose in international units/day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post Baseline values. A negative percent change from Baseline indicated a reduction in the amount of bolus insulin used and a positive percent change from Baseline indicated an increase in the amount of bolus insulin used between Baseline and Week 24.
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Timepoint [4]
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Baseline to Week 24
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Eligibility
Key inclusion criteria
- Participants 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 T1DM made at least 1 year
prior to informed consent
- Participants were 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 was between 7.0% to 11.0%
- Females of childbearing potential used an adequate method of contraception and had a
negative pregnancy test
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2017
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Sample size
Target
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Accrual to date
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Final
1405
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Lexicon Investigational Site - Coffs Harbour
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Recruitment hospital [2]
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Lexicon Investigational Site - Merewether
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Lexicon Investigational Site - St Leonards
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Lexicon Investigational Site - Box Hill
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Lexicon Investigational Site - Fitzroy
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Recruitment hospital [9]
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Lexicon Investigational Site - Parkville
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Recruitment postcode(s) [1]
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2450 - Coffs Harbour
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Recruitment postcode(s) [2]
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2291 - Merewether
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2065 - St Leonards
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2500 - Wollongong
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4029 - Herston
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Recruitment postcode(s) [6]
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5035 - Keswick
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Recruitment postcode(s) [7]
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3128 - Box Hill
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Recruitment postcode(s) [8]
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3065 - Fitzroy
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Recruitment postcode(s) [9]
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3050 - Parkville
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Lexicon Pharmaceuticals
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Address
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Sanofi
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Ethics approval
Ethics application status
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Summary
Brief summary
This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus
placebo in patients with Type 1 Diabetes (T1D).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02531035
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sangeeta Sawhney, MD
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Address
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Lexicon Pharmaceuticals, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02531035
Download to PDF