Evidence map›Paper›PMID 30833371›Full record

ArticleDiabetes care2019

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.

Thomas Danne, Bertrand Cariou, John B Buse, Satish K Garg, Julio Rosenstock, Phillip Banks, Jake A Kushner, Darren K McGuire, Anne L Peters, Sangeeta Sawhney and 1 more

2 registry-linked trialsOpen access · bronzeAbstract read
In one paragraph

Article in Diabetes care, 2019. 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 35 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 5 pooled it
7.3field-weighted citation impact, top 2% 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.

NCT02384941 phase3completednot on this map

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

TypeinterventionalSponsorLexicon PharmaceuticalsRan2015 to 2017Enrolled793ConditionsType 1 Diabetes MellitusArmsPlacebo, Sotagliflozin
NCT02421510 phase3completednot on this map

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

TypeinterventionalSponsorLexicon PharmaceuticalsRan2015 to 2017Enrolled782ConditionsType 1 Diabetes MellitusArmsSotagliflozin, Placebo
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 5 syntheses or guidelines pooled it, 63 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 3 countries.

Thomas DanneDepartment of Diabetes, Endocrinology, and Clinical Research, Children's and Youth Hospital Auf der Bult, Hannover Medical School, Hannover, Germany danne@hka.de.ORCID 0000-0003-0773-6961
Bertrand CariouL'institut du thorax, Department of Endocrinology, CIC 1413 INSERM, CHU Nantes, Nantes, France.ORCID 0000-0002-1580-8040
John B BuseDepartment of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.ORCID 0000-0002-9723-3876
Satish K GargDepartment of Medicine and Pediatrics, Barbara Davis Center for Diabetes, University of Colorado Denver, Aurora, CO.
Julio RosenstockDallas Diabetes Research Center at Medical City, Dallas, TX.ORCID 0000-0001-8324-3275
Phillip BanksLexicon Pharmaceuticals, Inc., The Woodlands, TX.
Jake A KushnerDepartment of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, TX.ORCID 0000-0002-3646-1744
Darren K McGuireDivision of Cardiology, Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX.ORCID 0000-0002-6412-7989
Anne L PetersKeck School of Medicine of the University of Southern California, Los Angeles, CA.
Sangeeta SawhneyLexicon Pharmaceuticals, Inc., The Woodlands, TX.
Paul StrumphLexicon Pharmaceuticals, Inc., The Woodlands, TX.
Lexicon Pharmaceuticals (United States) · USBaylor College of Medicine · USDallas Diabetes Research Center · USInserm · FRMedizinische Hochschule Hannover · DEThe University of Texas Southwestern Medical Center · USUniversity of Colorado Denver · USUniversity of North Carolina at Chapel Hill · USUniversity of Southern California · US

Funding

Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
NCATS NIH HHS UL1 TR002489
6 · The paper itself

Abstract

objectiveTo evaluate effects of the dual sodium-glucose cotransporter (SGLT) 1 and SGLT2 inhibitor sotagliflozin in combination with insulin on glucose time in range (TIR) and glucose excursions, postprandial glucose (PPG), and other glycemic metrics in adults with type 1 diabetes using masked continuous glucose monitoring (CGM). RESEARCH DESIGN AND

methodsData sets from the inTandem1 (clinical trial reg. no. NCT02384941) and inTandem2 (clinical trial reg. no. NCT02421510) double-blind randomized trials evaluating sotagliflozin versus placebo in adults with type 1 diabetes treated with optimized insulin were pooled for analyses of masked CGM data from a subset of participants in each trial. The pooled cohort included patients randomized to receive placebo (

resultsMean percentage of glucose TIR/percentage time spent at <3.9 mmol/L (<70 mg/dL) during week 24 was 51.6%/5.9%, 57.8%/5.5%, and 64.2%/5.5% with placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg, respectively, which corresponded to a placebo-adjusted change from a baseline of +5.4%/-0.3% (

conclusionsCombined with optimized insulin in type 1 diabetes, sotagliflozin significantly increased glucose TIR without increasing time spent at <3.9 mmol/L and reduced PPG, thereby improving glycemic control.

Indexed as

AdultAgedBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1Double-Blind MethodDrug Therapy, CombinationFemaleGlycosidesHumansHypoglycemic AgentsInsulinLongitudinal StudiesMaleMiddle AgedMulticenter Studies as Topic(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triolBlood GlucoseGlycosidesHypoglycemic AgentsInsulin

Identifiers

PMID30833371
PMCPMC6905498
OpenAlexW2918957897

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.