Evidence map›Paper›PMID 28899222›Full record

Trial reportThe New England journal of medicine2017

Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes.

Satish K Garg, Robert R Henry, Phillip Banks, John B Buse, Melanie J Davies, Gregory R Fulcher, Paolo Pozzilli, Diane Gesty-Palmer, Pablo Lapuerta, Rafael Simó and 5 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 185 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
185citing papers in PubMed, 21 pooled it
36.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02531035 phase3completednot on this map

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

TypeinterventionalSponsorLexicon PharmaceuticalsRan2015 to 2017Enrolled1,405ConditionsType 1 Diabetes Mellitus (T1DM), High Level of Sugar (Glucose) in the BloodArmsSotagliflozin, Placebo
NCT07325201 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Mitigating Diabetic Ketoacidosis in People With T1D and Chronic Kidney Disease on an SGLT1&2 Inhibitor: Ketosis Risk Factor Determination and Incorporation Into an Enhanced Glucose Ketone Report

TypeinterventionalSponsorHealthPartners InstituteRan2026 to 2030Enrolled80ConditionsType 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), Chronic Kidney Disease, Diabetic KetoacidosisArmsSotagliflozin initiation
3 · Its place in the literature

Who cites it

185 citing papers in PubMed, 21 syntheses or guidelines pooled it, 406 citations in OpenAlex.

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125 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 10 institutions in 6 countries.

Satish K GargFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Robert R HenryFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Phillip BanksFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
John B BuseFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Melanie J DaviesFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Gregory R FulcherFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Paolo PozzilliFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Diane Gesty-PalmerFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Pablo LapuertaFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Rafael SimóFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Thomas DanneFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Darren K McGuireFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Jake A KushnerFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Anne PetersFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Paul StrumphFrom the University of Colorado Denver, Aurora (S.K.G.); the University of California at San Diego, San Diego (R.R.H.); Lexicon Pharmaceuticals, The Woodlands (P.B., D.G.-P., P.L., P.S.), the University of Texas Southwestern Medical Center, Dallas (D.K.M.), and Baylor College of Medicine and Texas Children's Hospital, Houston (J.A.K.) - all in Texas; the Diabetes Research Center, University of North Carolina School of Medicine, Durham (J.B.B.); the University of Leicester and University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (M.J.D.); the University of Sydney, Sydney (G.R.F.); University Campus Bio-Medico of Rome, Rome (P.P.); Vall d'Hebron Research Institute, Barcelona, and CIBERDEM-Instituto de Salud Carlos III, Madrid (R.S.); Diabetes Center Auf der Bult, Hannover Medical School, Hannover, Germany (T.D.); and the University of Southern California, Los Angeles (A.P.).
Lexicon Pharmaceuticals (United States) · USBaylor College of Medicine · USInstituto de Salud Carlos III · ESMedizinische Hochschule Hannover · DEThe University of Texas Southwestern Medical Center · USUniversità Campus Bio-Medico · ITUniversity of Colorado Denver · USUniversity of Leicester · GBUniversity of Southern California · USUniversity of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn most patients with type 1 diabetes, adequate glycemic control is not achieved with insulin therapy alone. We evaluated the safety and efficacy of sotagliflozin, an oral inhibitor of sodium-glucose cotransporters 1 and 2, in combination with insulin treatment in patients with type 1 diabetes.

methodsIn this phase 3, double-blind trial, which was conducted at 133 centers worldwide, we randomly assigned 1402 patients with type 1 diabetes who were receiving treatment with any insulin therapy (pump or injections) to receive sotagliflozin (400 mg per day) or placebo for 24 weeks. The primary end point was a glycated hemoglobin level lower than 7.0% at week 24, with no episodes of severe hypoglycemia or diabetic ketoacidosis after randomization. Secondary end points included the change from baseline in glycated hemoglobin level, weight, systolic blood pressure, and mean daily bolus dose of insulin.

resultsA significantly larger proportion of patients in the sotagliflozin group than in the placebo group achieved the primary end point (200 of 699 patients [28.6%] vs. 107 of 703 [15.2%], P<0.001). The least-squares mean change from baseline was significantly greater in the sotagliflozin group than in the placebo group for glycated hemoglobin (difference, -0.46 percentage points), weight (-2.98 kg), systolic blood pressure (-3.5 mm Hg), and mean daily bolus dose of insulin (-2.8 units per day) (P≤0.002 for all comparisons). The rate of severe hypoglycemia was similar in the sotagliflozin group and the placebo group (3.0% [21 patients] and 2.4% [17], respectively). The rate of documented hypoglycemia with a blood glucose level of 55 mg per deciliter (3.1 mmol per liter) or below was significantly lower in the sotagliflozin group than in the placebo group. The rate of diabetic ketoacidosis was higher in the sotagliflozin group than in the placebo group (3.0% [21 patients] and 0.6% [4], respectively).

conclusionsAmong patients with type 1 diabetes who were receiving insulin, the proportion of patients who achieved a glycated hemoglobin level lower than 7.0% with no severe hypoglycemia or diabetic ketoacidosis was larger in the group that received sotagliflozin than in the placebo group. However, the rate of diabetic ketoacidosis was higher in the sotagliflozin group. (Funded by Lexicon Pharmaceuticals; inTandem3 ClinicalTrials.gov number, NCT02531035 .).

Indexed as

AdolescentAdultDiabetes Mellitus, Type 1Diabetic KetoacidosisDouble-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinGlycosidesHumansHypoglycemiaHypoglycemic AgentsInsulinIntention to Treat AnalysisLeast-Squares AnalysisMale(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triolGlycated HemoglobinGlycosidesHypoglycemic AgentsInsulinSodium-Glucose Transport Proteins

Identifiers

PMID28899222
OpenAlexW2755899227

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.