Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
North Dakota
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
South Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Argentina
State/province [20] 0 0
Cordoba
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Belgium
State/province [22] 0 0
Aalst
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Belgium
State/province [24] 0 0
Sint-Niklaas
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Plovdiv
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Ruse
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Smolyan
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sofia
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Varna
Country [30] 0 0
Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
Nova Scotia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Colombia
State/province [34] 0 0
Atlantico
Country [35] 0 0
Colombia
State/province [35] 0 0
Cundinamarca
Country [36] 0 0
Czechia
State/province [36] 0 0
Krnov
Country [37] 0 0
Czechia
State/province [37] 0 0
Olomouc
Country [38] 0 0
Czechia
State/province [38] 0 0
Ostrava
Country [39] 0 0
Czechia
State/province [39] 0 0
Praha 10
Country [40] 0 0
Czechia
State/province [40] 0 0
Praha 4
Country [41] 0 0
Czechia
State/province [41] 0 0
Praha 5
Country [42] 0 0
France
State/province [42] 0 0
Corbeil-Essonnes
Country [43] 0 0
France
State/province [43] 0 0
Pierre-Bénite
Country [44] 0 0
Germany
State/province [44] 0 0
Palatinate
Country [45] 0 0
Germany
State/province [45] 0 0
Rosenberg Bavaria
Country [46] 0 0
Germany
State/province [46] 0 0
Westphalia
Country [47] 0 0
Germany
State/province [47] 0 0
Aschaffenburg
Country [48] 0 0
Germany
State/province [48] 0 0
Asslar
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapest
Country [50] 0 0
Hungary
State/province [50] 0 0
Eger
Country [51] 0 0
Hungary
State/province [51] 0 0
Esztergom
Country [52] 0 0
Hungary
State/province [52] 0 0
Gyor
Country [53] 0 0
Hungary
State/province [53] 0 0
Sátoraljaújhely
Country [54] 0 0
Israel
State/province [54] 0 0
Holon
Country [55] 0 0
Israel
State/province [55] 0 0
Petach-Tikvah
Country [56] 0 0
Israel
State/province [56] 0 0
Petah Tikva
Country [57] 0 0
Israel
State/province [57] 0 0
Rehovot
Country [58] 0 0
Israel
State/province [58] 0 0
Tel Hashomer
Country [59] 0 0
Italy
State/province [59] 0 0
Bologna
Country [60] 0 0
Italy
State/province [60] 0 0
Catania
Country [61] 0 0
Italy
State/province [61] 0 0
Latina
Country [62] 0 0
Italy
State/province [62] 0 0
Milan
Country [63] 0 0
Italy
State/province [63] 0 0
Rome
Country [64] 0 0
New Zealand
State/province [64] 0 0
Auckland
Country [65] 0 0
New Zealand
State/province [65] 0 0
Canterbury
Country [66] 0 0
New Zealand
State/province [66] 0 0
Otago
Country [67] 0 0
New Zealand
State/province [67] 0 0
Wellington
Country [68] 0 0
New Zealand
State/province [68] 0 0
Christchurch
Country [69] 0 0
New Zealand
State/province [69] 0 0
Otahuhu
Country [70] 0 0
Poland
State/province [70] 0 0
Gdynia
Country [71] 0 0
Poland
State/province [71] 0 0
Katowice
Country [72] 0 0
Poland
State/province [72] 0 0
Lublin
Country [73] 0 0
Poland
State/province [73] 0 0
Warsaw
Country [74] 0 0
Poland
State/province [74] 0 0
Warszawa
Country [75] 0 0
Slovakia
State/province [75] 0 0
Bardejov
Country [76] 0 0
Slovakia
State/province [76] 0 0
Bratislava
Country [77] 0 0
Slovakia
State/province [77] 0 0
Levice
Country [78] 0 0
South Africa
State/province [78] 0 0
Cape Town
Country [79] 0 0
South Africa
State/province [79] 0 0
Mpumalanga
Country [80] 0 0
South Africa
State/province [80] 0 0
Bloemfontein
Country [81] 0 0
South Africa
State/province [81] 0 0
Johannesburg
Country [82] 0 0
South Africa
State/province [82] 0 0
Port Elizabeth
Country [83] 0 0
Spain
State/province [83] 0 0
Barcelona
Country [84] 0 0
Spain
State/province [84] 0 0
Malaga
Country [85] 0 0
Spain
State/province [85] 0 0
Sevilla
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Scotland
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Blackburn
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Guildford
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Leicester
Country [90] 0 0
United Kingdom
State/province [90] 0 0
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