search
Back to results

A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control (SOTA-CKD4)

Primary Purpose

Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 4

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Sotagliflozin
Sponsored by
Lexicon Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria :

  • Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented severe renal insufficiency - CKD4 - defined by an estimated glomerular filtration rate (eGFR) equation (based on the 4 variable modification of diet in renal disease (MDRD) equation) of ≥15 and <30 milliliter per minute (mL/min)/1.73 per meter square (m^2).
  • Signed written informed consent to participate in the study in accordance with local regulations.

Exclusion criteria:

  • At the time of screening, age <18 years.
  • Hemoglobin A1c (HbA1c) <7% or >11%.
  • Type 1 diabetes.
  • Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
  • Treatment with an sodium-glucose cotransporter type 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.
  • Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the Investigator believes with result in a short life expectancy, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
  • Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number 8405033
  • Investigational Site Number 8405005
  • Investigational Site Number 8405007
  • Investigational Site Number 8405015
  • Investigational Site Number 8405032
  • Investigational Site Number 8405003
  • Investigational Site Number 8405013
  • Investigational Site Number 8405018
  • Investigational Site Number 8405021
  • Investigational Site Number 8405001
  • Investigational Site Number 8405043
  • Investigational Site Number 8405006
  • Investigational Site Number 8405025
  • Investigational Site Number 8405039
  • Investigational Site Number 8405041
  • Investigational Site Number 8405030
  • Investigational Site Number 8405019
  • Investigational Site Number 8405034
  • Investigational Site Number 8405012
  • Investigational Site Number 8405035
  • Investigational Site Number 8405014
  • Investigational Site Number 8405027
  • Investigational Site Number 8405037
  • Investigational Site Number 8405038
  • Investigational Site Number 8405009
  • Investigational Site Number 8405004
  • Investigational Site Number 8405036
  • Investigational Site Number 8405020
  • Investigational Site Number 8405026
  • Investigational Site Number 8405047
  • Investigational Site Number 8405031
  • Investigational Site Number 8405016
  • Investigational Site Number 8405008
  • Investigational Site Number 8405040
  • Investigational Site Number 0325001
  • Investigational Site Number 0325003
  • Investigational Site Number 0325004
  • Investigational Site Number 0765003
  • Investigational Site Number 0765001
  • Investigational Site Number 0765004
  • Investigational Site Number 0765002
  • Investigational Site Number 1705004
  • Investigational Site Number 1705005
  • Investigational Site Number 1705002
  • Investigational Site Number 1705001
  • Investigational Site Number 2765001
  • Investigational Site Number 2765003
  • Investigational Site Number 2765004
  • Investigational Site Number 3485005
  • Investigational Site Number 3485007
  • Investigational Site Number 3485004
  • Investigational Site Number 3765002
  • Investigational Site Number 3765001
  • Investigational Site Number 3765007
  • Investigational Site Number 3765005
  • Investigational Site Number 3765004
  • Investigational Site Number 3765003
  • Investigational Site Number 3765006
  • Investigational Site Number 3805003
  • Investigational Site Number 3805005
  • Investigational Site Number 3805006
  • Investigational Site Number 3805002
  • Investigational Site Number 3805001
  • Investigational Site Number 3805004
  • Investigational Site Number 4845007
  • Investigational Site Number 4845001
  • Investigational Site Number 4845004
  • Investigational Site Number 4845008
  • Investigational Site Number 4845006
  • Investigational Site Number 4845003
  • Investigational Site Number 4845002
  • Investigational Site Number 4845005
  • Investigational Site Number 6165003
  • Investigational Site Number 6165002
  • Investigational Site Number 6165004
  • Investigational Site Number 6165005
  • Investigational Site Number 6165001
  • Investigational Site Number 6425005
  • Investigational Site Number 6425002
  • Investigational Site Number 6425003
  • Investigational Site Number 6425007
  • Investigational Site Number 6425004
  • Investigational Site Number 6425001
  • Investigational Site Number 6435004
  • Investigational Site Number 6435005
  • Investigational Site Number 6435003
  • Investigational Site Number 6435006
  • Investigational Site Number 6435001
  • Investigational Site Number 7105003
  • Investigational Site Number 7105004
  • Investigational Site Number 7105001
  • Investigational Site Number 7105002
  • Investigational Site Number 7245005
  • Investigational Site Number 7245007
  • Investigational Site Number 7245003
  • Investigational Site Number 7245009
  • Investigational Site Number 7245006
  • Investigational Site Number 7245004
  • Investigational Site Number 7245001
  • Investigational Site Number 7245002
  • Investigational Site Number 8045004
  • Investigational Site Number 8045006
  • Investigational Site Number 8045007
  • Investigational Site Number 8045003
  • Investigational Site Number 8045001
  • Investigational Site Number 8045002

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Sotagliflozin 200 mg

Sotagliflozin 400 mg

Arm Description

Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 milligrams [mg] in appearance) orally once daily for up to 56 weeks.

Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 56 weeks.

Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo
An analysis of covariance (ANCOVA) model was used for the analysis.

Secondary Outcome Measures

Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo
An ANCOVA model was used for the analysis.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
An ANCOVA model was used for the analysis.
Change From Baseline in Body Weight at Week 26
An ANCOVA model was used for the analysis.
Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg
An ANCOVA model was used for the analysis.
Change From Baseline in SBP at Week 12 for All Participants
An ANCOVA model was used for the analysis.
Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)
An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.
Percentage of Participants With HbA1c <6.5% at Week 26
Percentage of Participants With HbA1c <7.0% at Week 26
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP).

Full Information

First Posted
August 3, 2017
Last Updated
June 3, 2021
Sponsor
Lexicon Pharmaceuticals
Collaborators
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT03242018
Brief Title
A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
Acronym
SOTA-CKD4
Official Title
A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Severe Renal Impairment Who Have Inadequate Glycemic Control
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
May 16, 2019 (Actual)
Study Completion Date
December 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexicon Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic control and severe renal impairment Secondary Objectives: To assess the effects of sotagliflozin 200 mg versus placebo based on change from baseline in HbA1c To assess the effects of sotagloflozin 400 mg and 200 mg versus placebo To evaluate the safety of sotagliflozin 400 mg and 200 mg versus placebo
Detailed Description
The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment and a visit 4 weeks after completion of the randomized treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Following a 2-week run-in phase, participants received two placebo tablets (identical to sotagliflozin 200 milligrams [mg] in appearance) orally once daily for up to 56 weeks.
Arm Title
Sotagliflozin 200 mg
Arm Type
Experimental
Arm Description
Following a 2-week run-in phase, participants received two tablets, one sotagliflozin 200 mg tablet and one placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily for up to 56 weeks.
Arm Title
Sotagliflozin 400 mg
Arm Type
Experimental
Arm Description
Following a 2-week run-in phase, participants received sotagliflozin 400 mg, administered as 2 sotagliflozin 200 mg tablets, orally once daily for up to 56 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.
Intervention Type
Drug
Intervention Name(s)
Sotagliflozin
Other Intervention Name(s)
SAR439954
Intervention Description
Sotagliflozin 200 mg, tablet, orally, once daily.
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 400 mg Versus Placebo
Description
An analysis of covariance (ANCOVA) model was used for the analysis.
Time Frame
Baseline to Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c at Week 26 Comparing Sotagliflozin 200 mg Versus Placebo
Description
An ANCOVA model was used for the analysis.
Time Frame
Baseline to Week 26
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Description
An ANCOVA model was used for the analysis.
Time Frame
Baseline to Week 26
Title
Change From Baseline in Body Weight at Week 26
Description
An ANCOVA model was used for the analysis.
Time Frame
Baseline to Week 26
Title
Change From Baseline in SBP at Week 12 in Participants With Baseline SBP ≥130 mmHg
Description
An ANCOVA model was used for the analysis.
Time Frame
Baseline to Week 12
Title
Change From Baseline in SBP at Week 12 for All Participants
Description
An ANCOVA model was used for the analysis.
Time Frame
Baseline to Week 12
Title
Percentage Change From Baseline in the Urine Albumin: Creatinine Ratio (UACR) at Week 26 in Participants With Baseline UACR >30 Milligrams Per Gram (mg/g)
Description
An ANCOVA model was used for analysis. No Measure of Dispersion was pre-specified to be calculated.
Time Frame
Baseline to Week 26
Title
Percentage of Participants With HbA1c <6.5% at Week 26
Time Frame
Week 26
Title
Percentage of Participants With HbA1c <7.0% at Week 26
Time Frame
Week 26
Title
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a participants or clinical investigation participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP).
Time Frame
First dose of study drug to last dose of study drug (up to 56.3 weeks) + 4 weeks
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Hypoglycemic Events
Description
Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia [typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤ 70 mg/dL (3.9 mmol/L)]; Severe [an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions] or documented symptomatic hypoglycemia [typical symptoms of hypoglycemia and plasma glucose ≤ 70 mg/dL].
Time Frame
up to 56.3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria : Participants with Type 2 Diabetes (drug-naïve or on antidiabetic therapy) and documented severe renal insufficiency - CKD4 - defined by an estimated glomerular filtration rate (eGFR) equation (based on the 4 variable modification of diet in renal disease (MDRD) equation) of ≥15 and <30 milliliter per minute (mL/min)/1.73 per meter square (m^2). Signed written informed consent to participate in the study in accordance with local regulations. Exclusion criteria: At the time of screening, age <18 years. Hemoglobin A1c (HbA1c) <7% or >11%. Type 1 diabetes. Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study. Treatment with an sodium-glucose cotransporter type 2 (SGLT2) inhibitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months. Uncontrolled high blood pressure, severe anemia, severe cardiovascular problems, such as heart failure, active cancer, or other conditions that the Investigator believes with result in a short life expectancy, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult. Lower extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suman Wason, MD
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 8405033
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976-2206
Country
United States
Facility Name
Investigational Site Number 8405005
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018-2701
Country
United States
Facility Name
Investigational Site Number 8405007
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Investigational Site Number 8405015
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Investigational Site Number 8405032
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Investigational Site Number 8405003
City
Norco
State/Province
California
ZIP/Postal Code
92860-3611
Country
United States
Facility Name
Investigational Site Number 8405013
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Investigational Site Number 8405018
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Investigational Site Number 8405021
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761-2022
Country
United States
Facility Name
Investigational Site Number 8405001
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720-0834
Country
United States
Facility Name
Investigational Site Number 8405043
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-4630
Country
United States
Facility Name
Investigational Site Number 8405006
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761-4547
Country
United States
Facility Name
Investigational Site Number 8405025
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174-8187
Country
United States
Facility Name
Investigational Site Number 8405039
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Investigational Site Number 8405041
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005-4197
Country
United States
Facility Name
Investigational Site Number 8405030
City
Sellersburg
State/Province
Indiana
ZIP/Postal Code
47172-8932
Country
United States
Facility Name
Investigational Site Number 8405019
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Investigational Site Number 8405034
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532-3447
Country
United States
Facility Name
Investigational Site Number 8405012
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701-2669
Country
United States
Facility Name
Investigational Site Number 8405035
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Investigational Site Number 8405014
City
Bronx
State/Province
New York
ZIP/Postal Code
10455
Country
United States
Facility Name
Investigational Site Number 8405027
City
Laurelton
State/Province
New York
ZIP/Postal Code
11413
Country
United States
Facility Name
Investigational Site Number 8405037
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562-5200
Country
United States
Facility Name
Investigational Site Number 8405038
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigational Site Number 8405009
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419-4336
Country
United States
Facility Name
Investigational Site Number 8405004
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Investigational Site Number 8405036
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Investigational Site Number 8405020
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Investigational Site Number 8405026
City
Houston
State/Province
Texas
ZIP/Postal Code
77099-4307
Country
United States
Facility Name
Investigational Site Number 8405047
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Investigational Site Number 8405031
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Investigational Site Number 8405016
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249-2782
Country
United States
Facility Name
Investigational Site Number 8405008
City
Layton
State/Province
Utah
ZIP/Postal Code
84041-1200
Country
United States
Facility Name
Investigational Site Number 8405040
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Investigational Site Number 0325001
City
Buenos Aires
ZIP/Postal Code
C1425DES
Country
Argentina
Facility Name
Investigational Site Number 0325003
City
Launs Este
ZIP/Postal Code
B1824KAJ
Country
Argentina
Facility Name
Investigational Site Number 0325004
City
Mar Del Plata
ZIP/Postal Code
B7600
Country
Argentina
Facility Name
Investigational Site Number 0765003
City
Belém
ZIP/Postal Code
66073-005
Country
Brazil
Facility Name
Investigational Site Number 0765001
City
Fortaleza
ZIP/Postal Code
60170-195
Country
Brazil
Facility Name
Investigational Site Number 0765004
City
Rio De Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
Investigational Site Number 0765002
City
Sao Paulo
ZIP/Postal Code
01244-030
Country
Brazil
Facility Name
Investigational Site Number 1705004
City
Barranquilla
ZIP/Postal Code
80020
Country
Colombia
Facility Name
Investigational Site Number 1705005
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Investigational Site Number 1705002
City
Manizales
ZIP/Postal Code
170004
Country
Colombia
Facility Name
Investigational Site Number 1705001
City
Zipaquira
ZIP/Postal Code
250252
Country
Colombia
Facility Name
Investigational Site Number 2765001
City
Frankfurt Am Main
ZIP/Postal Code
60596
Country
Germany
Facility Name
Investigational Site Number 2765003
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Investigational Site Number 2765004
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Investigational Site Number 3485005
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Investigational Site Number 3485007
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Investigational Site Number 3485004
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Investigational Site Number 3765002
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Investigational Site Number 3765001
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Investigational Site Number 3765007
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Investigational Site Number 3765005
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Investigational Site Number 3765004
City
Rehovot
ZIP/Postal Code
7642001
Country
Israel
Facility Name
Investigational Site Number 3765003
City
Tel Aviv
ZIP/Postal Code
61480
Country
Israel
Facility Name
Investigational Site Number 3765006
City
Zefat
ZIP/Postal Code
13100
Country
Israel
Facility Name
Investigational Site Number 3805003
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Investigational Site Number 3805005
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Investigational Site Number 3805006
City
Napoli
ZIP/Postal Code
00181
Country
Italy
Facility Name
Investigational Site Number 3805002
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Investigational Site Number 3805001
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Investigational Site Number 3805004
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Investigational Site Number 4845007
City
Guadalajara Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Investigational Site Number 4845001
City
Guadalajara
ZIP/Postal Code
44210
Country
Mexico
Facility Name
Investigational Site Number 4845004
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Investigational Site Number 4845008
City
Merida, Yucatan
ZIP/Postal Code
97130
Country
Mexico
Facility Name
Investigational Site Number 4845006
City
Monterrey, N.L
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Investigational Site Number 4845003
City
Morelia
ZIP/Postal Code
58260
Country
Mexico
Facility Name
Investigational Site Number 4845002
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Investigational Site Number 4845005
City
Xalapa
ZIP/Postal Code
91020
Country
Mexico
Facility Name
Investigational Site Number 6165003
City
Krakow
ZIP/Postal Code
31-209
Country
Poland
Facility Name
Investigational Site Number 6165002
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
Facility Name
Investigational Site Number 6165004
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Investigational Site Number 6165005
City
Puławy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Investigational Site Number 6165001
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Investigational Site Number 6425005
City
Bacau
ZIP/Postal Code
600238
Country
Romania
Facility Name
Investigational Site Number 6425002
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Investigational Site Number 6425003
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Investigational Site Number 6425007
City
Hunedoara
ZIP/Postal Code
331057
Country
Romania
Facility Name
Investigational Site Number 6425004
City
Lasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
Investigational Site Number 6425001
City
Targu-Mures
ZIP/Postal Code
540142
Country
Romania
Facility Name
Investigational Site Number 6435004
City
Chelyabinsk
ZIP/Postal Code
4540
Country
Russian Federation
Facility Name
Investigational Site Number 6435005
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Investigational Site Number 6435003
City
Krasnodar
ZIP/Postal Code
350032
Country
Russian Federation
Facility Name
Investigational Site Number 6435006
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Investigational Site Number 6435001
City
Saint-Petersburg
ZIP/Postal Code
194358
Country
Russian Federation
Facility Name
Investigational Site Number 7105003
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Investigational Site Number 7105004
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Investigational Site Number 7105001
City
Johannesburg
ZIP/Postal Code
2188
Country
South Africa
Facility Name
Investigational Site Number 7105002
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Investigational Site Number 7245005
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number 7245007
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number 7245003
City
Ferrol
ZIP/Postal Code
15405
Country
Spain
Facility Name
Investigational Site Number 7245009
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Investigational Site Number 7245006
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Investigational Site Number 7245004
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number 7245001
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Investigational Site Number 7245002
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Investigational Site Number 8045004
City
Chernivtsi
ZIP/Postal Code
58022
Country
Ukraine
Facility Name
Investigational Site Number 8045006
City
Kiev
ZIP/Postal Code
02002
Country
Ukraine
Facility Name
Investigational Site Number 8045007
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Investigational Site Number 8045003
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Investigational Site Number 8045001
City
Kyiv
ZIP/Postal Code
3037
Country
Ukraine
Facility Name
Investigational Site Number 8045002
City
Zaporizhzhia
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34338408
Citation
Cherney DZI, Ferrannini E, Umpierrez GE, Peters AL, Rosenstock J, Carroll AK, Lapuerta P, Banks P, Agarwal R. Efficacy and safety of sotagliflozin in patients with type 2 diabetes and severe renal impairment. Diabetes Obes Metab. 2021 Dec;23(12):2632-2642. doi: 10.1111/dom.14513. Epub 2021 Aug 20.
Results Reference
derived

Learn more about this trial

A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

We'll reach out to this number within 24 hrs