Back to resultsA Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone (inTandem3)
Primary Purpose
Type 1 Diabetes Mellitus (T1DM), High Level of Sugar (Glucose) in the Blood
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sotagliflozin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus (T1DM)
Eligibility Criteria
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
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
Sites / Locations
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
- Lexicon Investigational Site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Sotagliflozin 400 mg
Arm Description
Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
Sotagliflozin 400 milligram (mg) (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Change From Baseline in A1C
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.
Absolute Change From Baseline in Body Weight
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.
Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg)
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.
Percent Change From Baseline in Mean Daily Bolus Insulin Dose
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.
Full Information
NCT ID
NCT02531035
First Posted
August 20, 2015
Last Updated
February 10, 2020
Sponsor
Lexicon Pharmaceuticals
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT02531035
Brief 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
Acronym
inTandem3
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexicon Pharmaceuticals
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus (T1DM), High Level of Sugar (Glucose) in the Blood
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1405 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two placebo-matching to sotagliflozin tablets daily, orally, before the first meal of the day for 24 weeks.
Arm Title
Sotagliflozin 400 mg
Arm Type
Experimental
Arm Description
Sotagliflozin 400 milligram (mg) (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Sotagliflozin
Other Intervention Name(s)
LX4211
Intervention Description
Sotagliflozin, once daily, before the first meal of the day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, once daily, before the first meal of the day
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in A1C
Description
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.
Time Frame
Baseline to Week 24
Title
Absolute Change From Baseline in Body Weight
Description
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.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg)
Description
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.
Time Frame
Baseline to Week 16
Title
Percent Change From Baseline in Mean Daily Bolus Insulin Dose
Description
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.
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeeta Sawhney, MD
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Lexicon Investigational Site
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Lexicon Investigational Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Lexicon Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Lexicon Investigational Site
City
San Marcos
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Lexicon Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Lexicon Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Lexicon Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Lexicon Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Lexicon Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Lexicon Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Lexicon Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Lexicon Investigational Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Lexicon Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Lexicon Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Lexicon Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Lexicon Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lexicon Investigational Site
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
Lexicon Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Lexicon Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Lexicon Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Lexicon Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Lexicon Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Lexicon Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Lexicon Investigational Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Lexicon Investigational Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Lexicon Investigational Site
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
Lexicon Investigational Site
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Lexicon Investigational Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Lexicon Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Lexicon Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Lexicon Investigational Site
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Lexicon Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Lexicon Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Lexicon Investigational Site
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
X5006IKK
Country
Argentina
Facility Name
Lexicon Investigational Site
City
Buenos Aires
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Lexicon Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Lexicon Investigational Site
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Lexicon Investigational Site
City
Merewether
State/Province
New South Wales
ZIP/Postal Code
2291
Country
Australia
Facility Name
Lexicon Investigational Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Lexicon Investigational Site
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Lexicon Investigational Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Lexicon Investigational Site
City
Keswick
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Lexicon Investigational Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Lexicon Investigational Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Lexicon Investigational Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Lexicon Investigational Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Lexicon Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Lexicon Investigational Site
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Lexicon Investigational Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Lexicon Investigational Site
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
Lexicon Investigational Site
City
Smolyan
ZIP/Postal Code
4700
Country
Bulgaria
Facility Name
Lexicon Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Lexicon Investigational Site
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
Lexicon Investigational Site
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Lexicon Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Y 3W2
Country
Canada
Facility Name
Lexicon Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Lexicon Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Lexicon Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Lexicon Investigational Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L6B 0P9
Country
Canada
Facility Name
Lexicon Investigational Site
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6M 1M1
Country
Canada
Facility Name
Lexicon Investigational Site
City
Thornhill
State/Province
Ontario
ZIP/Postal Code
L4J 8L7
Country
Canada
Facility Name
Lexicon Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Lexicon Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 5K2
Country
Canada
Facility Name
Lexicon Investigational Site
City
St. Laurent
State/Province
Quebec
ZIP/Postal Code
H4T 1Z9
Country
Canada
Facility Name
Lexicon Investigational Site
City
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Lexicon Investigational Site
City
Cundinamarca
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Lexicon Investigational Site
City
Cundinamarca
ZIP/Postal Code
111211
Country
Colombia
Facility Name
Lexicon Investigational Site
City
Cundinamarca
ZIP/Postal Code
111311
Country
Colombia
Facility Name
Lexicon Investigational Site
City
Krnov
ZIP/Postal Code
794 01
Country
Czechia
Facility Name
Lexicon Investigational Site
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Lexicon Investigational Site
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Lexicon Investigational Site
City
Praha 10
ZIP/Postal Code
104 00
Country
Czechia
Facility Name
Lexicon Investigational Site
City
Praha 4
ZIP/Postal Code
149 00
Country
Czechia
Facility Name
Lexicon Investigational Site
City
Praha 5
ZIP/Postal Code
150 98
Country
Czechia
Facility Name
Lexicon Investigational Site
City
Corbeil-Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
Lexicon Investigational Site
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Lexicon Investigational Site
City
Mainz
State/Province
Palatinate
ZIP/Postal Code
55116
Country
Germany
Facility Name
Lexicon Investigational Site
City
Sulzbach
State/Province
Rosenberg Bavaria
ZIP/Postal Code
92237
Country
Germany
Facility Name
Lexicon Investigational Site
City
Münster
State/Province
Westphalia
ZIP/Postal Code
48153
Country
Germany
Facility Name
Lexicon Investigational Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Lexicon Investigational Site
City
Asslar
ZIP/Postal Code
35614
Country
Germany
Facility Name
Lexicon Investigational Site
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Budapest
ZIP/Postal Code
1213
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Sátoraljaújhely
ZIP/Postal Code
3980
Country
Hungary
Facility Name
Lexicon Investigational Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Lexicon Investigational Site
City
Petach-Tikvah
ZIP/Postal Code
4920235
Country
Israel
Facility Name
Lexicon Investigational Site
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Lexicon Investigational Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Lexicon Investigational Site
City
Tel Hashomer
ZIP/Postal Code
56261
Country
Israel
Facility Name
Lexicon Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Lexicon Investigational Site
City
Catania
ZIP/Postal Code
95122
Country
Italy
Facility Name
Lexicon Investigational Site
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Lexicon Investigational Site
City
Latina
ZIP/Postal Code
04100
Country
Italy
Facility Name
Lexicon Investigational Site
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Lexicon Investigational Site
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
Lexicon Investigational Site
City
Epsom
State/Province
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Lexicon Investigational Site
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
0620
Country
New Zealand
Facility Name
Lexicon Investigational Site
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8001
Country
New Zealand
Facility Name
Lexicon Investigational Site
City
Dunedin
State/Province
Otago
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Lexicon Investigational Site
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Lexicon Investigational Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Lexicon Investigational Site
City
Otahuhu
ZIP/Postal Code
1640
Country
New Zealand
Facility Name
Lexicon Investigational Site
City
Gdynia
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Lexicon Investigational Site
City
Katowice
ZIP/Postal Code
40-060
Country
Poland
Facility Name
Lexicon Investigational Site
City
Katowice
ZIP/Postal Code
40-954
Country
Poland
Facility Name
Lexicon Investigational Site
City
Lublin
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Lexicon Investigational Site
City
Warsaw
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Lexicon Investigational Site
City
Warsaw
ZIP/Postal Code
04-736
Country
Poland
Facility Name
Lexicon Investigational Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Lexicon Investigational Site
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Lexicon Investigational Site
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Facility Name
Lexicon Investigational Site
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
Lexicon Investigational Site
City
Levice
ZIP/Postal Code
934 01
Country
Slovakia
Facility Name
Lexicon Investigational Site
City
Goodwood
State/Province
Cape Town
ZIP/Postal Code
7460
Country
South Africa
Facility Name
Lexicon Investigational Site
City
Middelburg
State/Province
Mpumalanga
ZIP/Postal Code
1055
Country
South Africa
Facility Name
Lexicon Investigational Site
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Lexicon Investigational Site
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Lexicon Investigational Site
City
Cape Town
ZIP/Postal Code
7580
Country
South Africa
Facility Name
Lexicon Investigational Site
City
Johannesburg
ZIP/Postal Code
2198
Country
South Africa
Facility Name
Lexicon Investigational Site
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Lexicon Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Lexicon Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Lexicon Investigational Site
City
Malaga
ZIP/Postal Code
29006
Country
Spain
Facility Name
Lexicon Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Lexicon Investigational Site
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Lexicon Investigational Site
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
Blackburn
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Lexicon Investigational Site
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28899222
Citation
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.
Results Reference
derived
Learn more about this trial
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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