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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
LX4211.312
Secondary ID [2] 0 0
LX4211.1-312-T1DM
Universal Trial Number (UTN)
Trial acronym
inTandem3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus (T1DM) 0 0
High Level of Sugar (Glucose) in the Blood 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Change From Baseline in A1C
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [2] 0 0
Absolute Change From Baseline in Body Weight
Timepoint [2] 0 0
Baseline to Week 24
Secondary outcome [3] 0 0
Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg)
Timepoint [3] 0 0
Baseline to Week 16
Secondary outcome [4] 0 0
Percent Change From Baseline in Mean Daily Bolus Insulin Dose
Timepoint [4] 0 0
Baseline to Week 24

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2017
Sample size
Target
Accrual to date
Final
1405
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Lexicon Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
Lexicon Investigational Site - Merewether
Recruitment hospital [3] 0 0
Lexicon Investigational Site - St Leonards
Recruitment hospital [4] 0 0
Lexicon Investigational Site - Wollongong
Recruitment hospital [5] 0 0
Lexicon Investigational Site - Herston
Recruitment hospital [6] 0 0
Lexicon Investigational Site - Keswick
Recruitment hospital [7] 0 0
Lexicon Investigational Site - Box Hill
Recruitment hospital [8] 0 0
Lexicon Investigational Site - Fitzroy
Recruitment hospital [9] 0 0
Lexicon Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
5035 - Keswick
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment outside Australia
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United States of America
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California
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Colorado
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Cordoba
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Wellington
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Christchurch
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Gdynia
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Sevilla
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Scotland
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Blackburn
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Guildford
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Leicester
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Northampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lexicon Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/study/NCT02531035
Trial related presentations / publications
Garg SK, Henry RR, Banks P, Buse JB, Davies MJ, Fulcher GR, Pozzilli P, Gesty-Palmer D, Lapuerta P, Simo R, Danne T, McGuire DK, Kushner JA, Peters A, Strumph P. Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes. N Engl J Med. 2017 Dec 14;377(24):2337-2348. doi: 10.1056/NEJMoa1708337. Epub 2017 Sep 13.
Public notes

Contacts
Principal investigator
Name 0 0
Sangeeta Sawhney, MD
Address 0 0
Lexicon Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02531035