Evidence map›Paper›PMID 23630033›Full record

Trial reportClinical cardiology2013

Study design and rationale of a dose-ranging trial of LX4211, a dual inhibitor of SGLT1 and SGLT2, in type 2 diabetes inadequately controlled on metformin monotherapy.

Pablo Lapuerta, Julio Rosenstock, Brian Zambrowicz, David R Powell, Ike Ogbaa, Joel Freiman, William T Cefalu, Phillip Banks, Kenny Frazier, Mike Kelly and 1 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical cardiology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 23% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Novel Agents for the Treatment of Type 2 Diabetes.Diabetes spectrum : a publication of the American Diabetes Association · 2014
    Article
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 3 institutions in 1 country.

Pablo LapuertaDepartment of Clinical Development, Lexicon Pharmaceuticals, Inc., 350 Carter Road, Princeton, NJ 08540, USA. plapuerta@lxrx.com
Julio Rosenstock
Brian Zambrowicz
David R Powell
Ike Ogbaa
Joel Freiman
William T Cefalu
Phillip Banks
Kenny Frazier
Mike Kelly
Arthur Sands
Lexicon Pharmaceuticals (United States) · USDallas Diabetes Research Center · USLouisiana State University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Sodium-glucose cotransporters 1 (SGLT1) and 2 (SGLT2) are the major cellular transporters responsible for gastrointestinal (GI) glucose absorption and renal glucose reabsorption, respectively. LX4211, a dual inhibitor of SGLT1 and SGLT2, reduces glucose absorption from the GI tract and enhances urinary glucose excretion. Although several SGLT2-selective inhibitors have been tested in large phase 2 studies, dual inhibition of SGLT1 and SGLT2 is novel at this stage of drug development, and it has implications for clinical-trial design. In this article, we describe the design and rationale of a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of LX4211 in subjects with type 2 diabetes mellitus who have inadequate glycemic control on metformin monotherapy. The primary endpoint is the change in glycated hemoglobin A1c from baseline to week 12. Secondary endpoints include the proportion of subjects achieving a glycated hemoglobin A1c value of <7%, change from baseline in fasting plasma glucose and postprandial glucose (as part of an oral glucose tolerance test), body weight, and blood pressure. Safety is evaluated with particular focus on hypoglycemia, GI symptoms, and incidence of genitourinary tract infections.

Indexed as

Research DesignSodium-Glucose Transporter 2 InhibitorsBiomarkersBlood GlucoseClinical ProtocolsDiabetes Mellitus, Type 2Double-Blind MethodFemaleGastrointestinal DiseasesGlycated HemoglobinGlycosidesHumansHypoglycemiaHypoglycemic AgentsMaleMetformin(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triolBiomarkersBlood GlucoseGlycated HemoglobinGlycosideshemoglobin A1c protein, humanHypoglycemic AgentsMetforminSLC5A1 protein, humanSLC5A2 protein, humanSodium-Glucose Transporter 1Sodium-Glucose Transporter 2Sodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID23630033
PMCPMC6649411
OpenAlexW1484963749

What OpenQuestion holds

Texttitle and abstract
Read underepoch 390

Registered trials

None linked

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.