24-week efficacy and safety of sotagliflozin

24-week efficacy and safety of sotagliflozin

2019-3-27 · The inTandem 2 study: 52-week efficacy and safety of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in adults with type 1 diabetes Abstract # 112 Session: SGLT2 inhibitors: new mechanisms and clinical evidence

2017-6-9 · 24-Week Efficacy and Safety of Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes (inTandem2, NCT02421510) Thomas Danne 1 , Bertrand Cariou 2 , Philip Banks 3 , Sangeeta Sawhney 3 , and Paul Strumph 3 on behalf of The inTandem2 Writing Group 4

2017-11-22 · A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Empagliflozin, and Placebo in Participants With Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin

2021-1-6 · 52-week, phase 3 trials, inTandem1 (NCT02384941) and inTandem2 (NCT02421510), which assessed the safety and efficacy of sotagliflozin 200 mg or 400 mg after a 6-week insulin optimization run-in period.4,5 Each study comprised a 24-week core treatment period, followed by a 28-week extension period. The primary efficacy

Objective: The objective of this study was to evaluate the efficacy and safety of the dual sodium-glucose cotransporter 1 and 2 inhibitor sotagliflozin compared with placebo when combined with optimized insulin in adults with type 1 diabetes (T1D). Research design and methods: In a double-blind, 52-week, international phase 3 trial, adults with T1D were randomized to placebo (n = 258) or once ...

2021-6-24 · Collectively, 24-week data from the two pivotal inTandem1 and inTandem2 studies for sotagliflozin in patients with type 1 diabetes demonstrated the following: Sotagliflozin 200 mg and 400 mg on top of optimized insulin significantly reduced A1C compared to placebo (p<0.001 in both studies). Sotagliflozin was generally well tolerated.

2020-8-14 · Sotagliflozin (SOTA) is a novel SGLT-1/SGLT-2 dual inhibitor. Relying on its unique hypoglycemic mechanism, it reduces the absorption of glucose in the gastrointestinal tract by inhibiting SGLT-1 and increases the excretion of glucose by the kidneys by inhibiting SGLT-2.

Efficacy and safety of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes mellitus: Results of a 24-week, randomized, double-blind, ... to week 24 was −0.88% (least-squares mean, P < .001). Fasting plasma glucose, body weight

2015-4-20 · 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.

2018-12-3 · Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

2018-12-3 · Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Here, we present results of the 52-week DEPICT-2 study, con-sisting of the 24-week short-term period plus a 28-week extension, which aimed to assess the long-term efficacy and safety of dapagliflozin in people with T1D. Safety data are aggregated for the 56-week study period, including the 4-week follow-up period. 2 | MATERIALS AND METHODS

Sotagliflozin (SOTA) is a dual SGLT1 and SGLT2 inhibitor in development as adjunct therapy to insulin in T1D. In this double-blind, 52-week study, 782 adults with T1D treated with multiple daily insulin injections or pump therapy were randomized 1:1:1 to placebo (n=258), SOTA 200 mg (n=261) or SOTA 400 mg (n=263) once daily after 6 weeks of insulin optimization.

2017-9-14 · Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Dr Paresh Dandona, MD . ... Sotagliflozin, a dual SGLT1 …

2019-11-19 · The present report describes results from the 28-week open-label extension period to assess the long-term (52-week) efficacy and safety of ipragliflozin. Patients in the ipragliflozin group from the double-blind phase continued ipragliflozin, and patients in the placebo group were switched to 50 mg ipragliflozin at the start of the extension ...

2020-11-24 · November 24, 2020 – Efficacy and safety of adding sotagliflozin, a dual sodium-glucose co-transporter (SGLT)1 and SGLT2 inhibitor, to optimized insulin therapy in adults with type 1 diabetes and baseline body mass index ≥ 27 kg/m2

2019-2-28 · Sotagliflozin is a dual sodium–glucose co-transporter-2 and 1 (SGLT2/1) inhibitor for the treatment of both type 1 (T1D) and type 2 diabetes (T2D). Sotagliflozin inhibits renal sodium–glucose co-transporter 2 (determining significant excretion of glucose in the urine, in the same way as other, already available SGLT-2 selective inhibitors) and intestinal SGLT-1, delaying glucose absorption ...

2020-8-26 · Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol 2017 ; 5: 864 – 876 .

2017-9-13 · Sotagliflozin (LX4211) is a new oral inhibitor of sodium–glucose cotransporters 1 and 2 (SGLT1 and SGLT2). SGLT1 inhibition reduces glucose …

2019-11-22 · Sotagliflozin is a new type of diabetes drug This study is to compare the efficacy of Sotagliflozin therapy for Diabetes Mellitus (DM) between week 24 with week 52. Methods and analysis: Through to October 2019, Web of Science, PubMed Database, Cochrane Library, EMBASE, Clinical Trials and CNKI will be searched to identify randomized controlled ...

2017-2-28 · Primary Objective: To demonstrate the superiority of Sotagliflozin 400 milligrams (mg) versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in participant with type 2 diabetes (T2D) who have inadequate glycemic control with a Sulfonylurea alone or in …

2020-1-21 · Sotagliflozin is a new type of diabetes drug This study is to compare the efficacy of Sotagliflozin therapy for Diabetes Mellitus (DM) between week 24 with week 52. Methods and analysis: Through to October 2019, Web of Science, PubMed Database, Cochrane Library, EMBASE, Clinical Trials and CNKI will be searched to identify randomized controlled ...

Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial Author links open overlay panel Dr Paresh Dandona MD a Chantal Mathieu MD b Moshe Phillip MD c d Lars Hansen MD e Steven C Griffen MD f Diethelm Tschöpe ...

2017-9-13 · 133 sites in 19 countries, evaluated the safety and efficacy of sotagliflozin in combination with insulin therapy (pump or injections) in patients ... bin level lower than 7.0% at week 24, with no

2020-10-17 · Effectiveness and safety of sotagliflozin adjuvant therapy for type 1 diabetes mellitus ... The stronger evidence about the efficacy and safety of SOTA for T1DM patients will be provided for clinicians. ... a pooled analysis of 24-week continuous glucose monitoring data from the inTandem program. Diabetes Care 2019;42:919–30. ...

Sotagliflozin (SOTA) is a dual SGLT1 and SGLT2 inhibitor in development as adjunct therapy to insulin in T1D. In this double-blind, 52-week North American trial, 793 adults with T1D treated with multiple daily insulin injections (40%) or pump (60%) were randomized 1:1:1 to placebo (n=268), SOTA 200 mg (n=263) or SOTA 400 mg (n=262) once daily after 6 weeks of insulin optimization.

2017-11-22 · A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Empagliflozin, and Placebo in Participants With Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin: Actual Study Start Date :

2019-3-27 · 24-week efficacy and safety of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in type 1 diabetes (inTandem1) ePoster # 885 Session: SGLT2 inhibitors: new class members and combinations

Objective: We evaluated the efficacy and safety of tofacitinib in patients with rheumatoid arthritis (RA) in a real-world setting. Methods: Seventy consecutive patients, for whom tofacitinib was initiated between November 2013 and May 2016, were enrolled. All patients fulfilled the 2010 ACR/EULAR classification criteria for RA. All patients received 5 mg of tofacitinib twice daily and were ...

2020-12-2 · Sotagliflozin, a dual sodium-glucose co-transporter (SGLT)1/SGLT2 inhibitor, is currently approved in Europe as an adjunct to optimal insulin therapy in adults with type 1 diabetes (T1D) and a body mass index (BMI) ≥ 27 kg/m 2.In this post hoc analysis, efficacy at 24 weeks and safety at 52 weeks from pooled phase 3 clinical trials were evaluated in patients with baseline BMI ≥ 27 kg/m 2.

In this post hoc analysis, efficacy at 24 weeks and safety at 52 weeks from pooled phase 3 clinical trials were evaluated in patients with baseline BMI ≥27 kg/m 2. Sotagliflozin 200 and 400 mg added to insulin reduced HbA1c and increased time-in-range by continuous glucose monitoring vs placebo and also reduced body weight and systolic blood pressure.

2018-9-24 · “The inTandem1 study: 52-week efficacy and safety of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in adults with type 1 diabetes” (#609) “inTandem1 and inTandem2: increased time in range with sotagliflozin as adjunct therapy to insulin in adults with type 1 diabetes by 24-week continuous glucose ...

2019-10-23 · Investigators compared the 24-week efficacy and 52-week safety of sotagliflozin 200 and 400 mg as an adjunct to insulin against optimized insulin alone in patients enrolled in the inTandem1 and 2** trials (n=916) with a baseline body mass index (BMI) of ≥27 kg/m². [EASD 2019, abstract OP2]

OBJECTIVE The objective of this study was to evaluate the efficacy and safety of the dual sodium–glucose cotransporter 1 and 2 inhibitor sotagliflozin compared with placebo when combined with optimized insulin in adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS In a double-blind, 52-week, international phase 3 trial, adults with T1D were randomized to placebo (n = …