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Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy (inTandem2)

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Sotagliflozin

Placebo

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring High level of sugar (glucose) in the blood

Eligibility Criteria

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

Inclusion Criteria:

Participant who gave written informed consent to participate in the study in accordance with local regulations.
Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent.
Participants treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI).
Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol.
At the Screening Visit, A1C was between 7.0% to 11.0%.
Females of childbearing potential must use an adequate method of contraception and have 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Sotagliflozin 200 mg

Sotagliflozin 400 mg

Arm Description

Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.

Sotagliflozin 200 milligram (mg) (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.

Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.

Outcomes

Primary Outcome Measures

Change From Baseline in A1C at Week 24

Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (<= 8.5%, >8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from baseline (a reduction of A1C value at Week 24) indicates an improvement.

Secondary 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) From Baseline to Week 24

The composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value <7.0% and a central blinded adjudication process to determine whether participants experienced either DKA or severe hypoglycemia. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.

Change From Baseline in Body Weight at Week 24

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 Mean Daily Bolus Insulin Dose at Week 24

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 change from baseline indicated a reduction in the amount of bolus insulin used and a positive change from baseline indicated an increase in the amount of bolus insulin used between baseline and Week 24.

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

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 change from baseline indicates a lower glucose level at Week 24 compared to baseline and a positive change from baseline indicates an increase in glucose level at Week 24 compared to baseline.

Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24

The DTSQ instrument contains 8 items assessing overall treatment satisfaction, treatment convenience and flexibility, satisfaction with understanding of diabetes, willingness to continue present treatment and to recommend it to others, and frequency of unacceptably high and unacceptably low blood glucose levels. 6 items (1, 4, 5, 6, 7 and 8) (excluding perceived hyperglycemia and hypoglycemia items) were scored using a 7- point scale where 0=very dissatisfied to 6= very satisfied for a total possible score of 0 (very dissatisfied) to 36 (very satisfied), where higher scores indicate higher satisfaction from treatment. Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively. 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 positive change from baseline indicates improvement.

Change From Baseline in 2-Item Diabetes Distress Screen 2 (DDS2) Score at Week 24

DDS2 is a 2-item diabetes distress screening instrument where participants rated the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen using a 6-point scale: where 1=no distress to 6=severe distress for a total possible score of 2 to 12. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates improvement.

Percent Change From Baseline in Body Weight at Week 24

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 percent change from baseline indicates a loss in body weight from baseline to Week 24.

Full Information

NCT ID

NCT02421510

First Posted

April 15, 2015

Last Updated

February 10, 2020

Sponsor

Lexicon Pharmaceuticals

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02421510

Brief Title

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

Acronym

inTandem2

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

May 2015 (Actual)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

June 23, 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 intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

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

782 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.

Arm Title

Sotagliflozin 200 mg

Arm Type

Experimental

Arm Description

Sotagliflozin 200 milligram (mg) (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.

Arm Title

Sotagliflozin 400 mg

Arm Type

Experimental

Arm Description

Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.

Intervention Type

Drug

Intervention Name(s)

Sotagliflozin

Intervention Description

High dose Sotagliflozin, once daily, before the first meal of the day

Intervention Type

Drug

Intervention Name(s)

Sotagliflozin

Intervention Description

Low dose 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

Change From Baseline in A1C at Week 24

Description

Time Frame

Baseline to Week 24

Secondary 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) From Baseline to Week 24

Description

Time Frame

Baseline to Week 24

Title

Change From Baseline in Body Weight at Week 24

Description

Time Frame

Baseline to Week 24

Title

Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24

Description

Time Frame

Baseline to Week 24

Title

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

Description

Time Frame

Baseline to Week 24

Title

Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24

Description

Time Frame

Baseline to Week 24

Title

Change From Baseline in 2-Item Diabetes Distress Screen 2 (DDS2) Score at Week 24

Description

Time Frame

Baseline to Week 24

Title

Percent Change From Baseline in Body Weight at Week 24

Description

Time Frame

Baseline to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant who gave written informed consent to participate in the study in accordance with local regulations. Adult participants 18 years and older with a diagnosis of T1D made at least 1 year prior to informed consent. Participants treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). Willing and were able to perform Self-monitoring of blood glucose (SMBG) and completed the study diary as required per protocol. At the Screening Visit, A1C was between 7.0% to 11.0%. Females of childbearing potential must use an adequate method of contraception and have 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, M.D.

Organizational Affiliation

Lexicon Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Lexicon Investigational Site

City

Linz

ZIP/Postal Code

4021

Country

Austria

Facility Name

Lexicon Investigational Site

City

Vienna

ZIP/Postal Code

1010

Country

Austria

Facility Name

Lexicon Investigational Site

City

Vienna

ZIP/Postal Code

1030

Country

Austria

Facility Name

Lexicon Investigational Site

City

Vienna

ZIP/Postal Code

1130

Country

Austria

Facility Name

Lexicon Investigational Site

City

Vienna

ZIP/Postal Code

1160

Country

Austria

Facility Name

Lexicon Investigational Site

City

Antwerp

ZIP/Postal Code

2018

Country

Belgium

Facility Name

Lexicon Investigational Site

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Lexicon Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Lexicon Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Lexicon Investigational Site

City

Sint Niklaas

ZIP/Postal Code

9100

Country

Belgium

Facility Name

Lexicon Investigational Site

City

Lovech

ZIP/Postal Code

5500

Country

Bulgaria

Facility Name

Lexicon Investigational Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Lexicon Investigational Site

City

Ruse

ZIP/Postal Code

7002

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

1750

Country

Bulgaria

Facility Name

Lexicon Investigational Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Lexicon Investigational Site

City

Beziers

ZIP/Postal Code

34500

Country

France

Facility Name

Lexicon Investigational Site

City

Dijon cedex

ZIP/Postal Code

21079

Country

France

Facility Name

Lexicon Investigational Site

City

Nantes

ZIP/Postal Code

44000

Country

France

Facility Name

Lexicon Investigational Site

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Lexicon Investigational Site

City

Nîmes

ZIP/Postal Code

30029

Country

France

Facility Name

Lexicon Investigational Site

City

Duesseldorf

ZIP/Postal Code

40210

Country

Germany

Facility Name

Lexicon Investigational Site

City

Hamburg

ZIP/Postal Code

21073

Country

Germany

Facility Name

Lexicon Investigational Site

City

Hamburg

ZIP/Postal Code

22607

Country

Germany

Facility Name

Lexicon Investigational Site

City

Hannover

ZIP/Postal Code

30173

Country

Germany

Facility Name

Lexicon Investigational Site

City

Mainz

ZIP/Postal Code

55116

Country

Germany

Facility Name

Lexicon Investigational Site

City

Muenster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Lexicon Investigational Site

City

Neuwied

ZIP/Postal Code

56564

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

1042

Country

Hungary

Facility Name

Lexicon Investigational Site

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

Lexicon Investigational Site

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Lexicon Investigational Site

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Lexicon Investigational Site

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Lexicon Investigational Site

City

Hodmezovasarhely

ZIP/Postal Code

6800

Country

Hungary

Facility Name

Lexicon Investigational Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Lexicon Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Lexicon Investigational Site

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Lexicon Investigational Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Lexicon Investigational Site

City

Petah Tikva

ZIP/Postal Code

49202

Country

Israel

Facility Name

Lexicon Investigational Site

City

Tel Aviv

ZIP/Postal Code

61480

Country

Israel

Facility Name

Lexicon Investigational Site

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Lexicon Investigational Site

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Lexicon Investigational Site

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Lexicon Investigational Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Lexicon Investigational Site

City

Palermo

ZIP/Postal Code

90127

Country

Italy

Facility Name

Lexicon Investigational Site

City

Perugia

ZIP/Postal Code

06126

Country

Italy

Facility Name

Lexicon Investigational Site

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Lexicon Investigational Site

City

Roma

ZIP/Postal Code

00128

Country

Italy

Facility Name

Lexicon Investigational Site

City

Jonava

ZIP/Postal Code

LT-55201

Country

Lithuania

Facility Name

Lexicon Investigational Site

City

Kaunas

ZIP/Postal Code

LT-49449

Country

Lithuania

Facility Name

Lexicon Investigational Site

City

Kaunas

ZIP/Postal Code

LT-50161

Country

Lithuania

Facility Name

Lexicon Investigational Site

City

Dordrecht

ZIP/Postal Code

3318

Country

Netherlands

Facility Name

Lexicon Investigational Site

City

Katowice

ZIP/Postal Code

40-060

Country

Poland

Facility Name

Lexicon Investigational Site

City

Kraków

ZIP/Postal Code

30-015

Country

Poland

Facility Name

Lexicon Investigational Site

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

Lexicon Investigational Site

City

Lublin

ZIP/Postal Code

20-538

Country

Poland

Facility Name

Lexicon Investigational Site

City

Poznan

ZIP/Postal Code

61-655

Country

Poland

Facility Name

Lexicon Investigational Site

City

Szczecin

ZIP/Postal Code

70-506

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

01-518

Country

Poland

Facility Name

Lexicon Investigational Site

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Lexicon Investigational Site

City

Bacau

ZIP/Postal Code

600238

Country

Romania

Facility Name

Lexicon Investigational Site

City

Bucuresti

ZIP/Postal Code

010507

Country

Romania

Facility Name

Lexicon Investigational Site

City

Bucuresti

ZIP/Postal Code

013764

Country

Romania

Facility Name

Lexicon Investigational Site

City

Buzau

ZIP/Postal Code

120203

Country

Romania

Facility Name

Lexicon Investigational Site

City

Galati

ZIP/Postal Code

800098

Country

Romania

Facility Name

Lexicon Investigational Site

City

Oradea

ZIP/Postal Code

410159

Country

Romania

Facility Name

Lexicon Investigational Site

City

Sibiu

ZIP/Postal Code

550371

Country

Romania

Facility Name

Lexicon Investigational Site

City

Targu-Mures

ZIP/Postal Code

540142

Country

Romania

Facility Name

Lexicon Investigational Site

City

Bratislava

ZIP/Postal Code

821 02

Country

Slovakia

Facility Name

Lexicon Investigational Site

City

Bratislava

ZIP/Postal Code

851 01

Country

Slovakia

Facility Name

Lexicon Investigational Site

City

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Lexicon Investigational Site

City

Nove Zamky

ZIP/Postal Code

940 01

Country

Slovakia

Facility Name

Lexicon Investigational Site

City

Sturovo

ZIP/Postal Code

943 01

Country

Slovakia

Facility Name

Lexicon Investigational Site

City

Vrutky

ZIP/Postal Code

038 61

Country

Slovakia

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

Granada

ZIP/Postal Code

18012

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

41003

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

41010

Country

Spain

Facility Name

Lexicon Investigational Site

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

Lexicon Investigational Site

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Lexicon Investigational Site

City

Härnösand

ZIP/Postal Code

871 82

Country

Sweden

Facility Name

Lexicon Investigational Site

City

Kristianstad

ZIP/Postal Code

291 85

Country

Sweden

Facility Name

Lexicon Investigational Site

City

Stockholm

ZIP/Postal Code

112 21

Country

Sweden

Facility Name

Lexicon Investigational Site

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Lexicon Investigational Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Lexicon Investigational Site

City

Blackburn

ZIP/Postal Code

BB2 3HH

Country

United Kingdom

Facility Name

Lexicon Investigational Site

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Lexicon Investigational Site

City

Glasgow

ZIP/Postal Code

G4 0SF

Country

United Kingdom

Facility Name

Lexicon Investigational Site

City

Leeds

ZIP/Postal Code

LS2 9JT

Country

United Kingdom

Facility Name

Lexicon Investigational Site

City

Leicester

ZIP/Postal Code

LE5 4PW

Country

United Kingdom

Facility Name

Lexicon Investigational Site

City

Sheffield

ZIP/Postal Code

S5 7AU

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

32928957

Citation

Peters AL, McGuire DK, Danne T, Kushner JA, Rodbard HW, Dhatariya K, Sawhney S, Banks P, Jiang W, Davies MJ, Lapuerta P. Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies. Diabetes Care. 2020 Nov;43(11):2713-2720. doi: 10.2337/dc20-0924. Epub 2020 Sep 14.

Results Reference

derived

PubMed Identifier

32721228

Citation

Danne T, Joish VN, Afonso M, Banks P, Sawhney S, Lapuerta P, Davies MJ, Buse JB, Lin D, Reaney M, Guillonneau S, Snoek FJ, Bailey TS, Polonsky WH. Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone. Diabetes Technol Ther. 2021 Jan;23(1):70-77. doi: 10.1089/dia.2020.0068.

Results Reference

derived

PubMed Identifier

31587812

Citation

Ervin C, Joish VN, Evans E, DiBenedetti D, Reaney M, Preblick R, Castro R, Danne T, Buse JB, Lapuerta P. Insights Into Patients' Experience With Type 1 Diabetes: Exit Interviews From Phase III Studies of Sotagliflozin. Clin Ther. 2019 Nov;41(11):2219-2230.e6. doi: 10.1016/j.clinthera.2019.09.003. Epub 2019 Oct 3.

Results Reference

derived

PubMed Identifier

30833371

Citation

Danne T, Cariou B, Buse JB, Garg SK, Rosenstock J, Banks P, Kushner JA, McGuire DK, Peters AL, Sawhney S, Strumph P. Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program. Diabetes Care. 2019 May;42(5):919-930. doi: 10.2337/dc18-2149. Epub 2019 Mar 4.

Results Reference

derived

PubMed Identifier

29937431

Citation

Danne T, Cariou B, Banks P, Brandle M, Brath H, Franek E, Kushner JA, Lapuerta P, McGuire DK, Peters AL, Sawhney S, Strumph P. HbA1c and Hypoglycemia Reductions at 24 and 52 Weeks With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: The European inTandem2 Study. Diabetes Care. 2018 Sep;41(9):1981-1990. doi: 10.2337/dc18-0342. Epub 2018 Jun 24.

Results Reference

derived

Learn more about this trial

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

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Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy (inTandem2)

Type 1 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial