Evidence mapPaperPMID 33372185Full record

Trial reportScientific reports2020

Dapagliflozin effects on haematocrit, red blood cell count and reticulocytes in insulin-treated patients with type 2 diabetes.

Jens Aberle, Markus Menzen, Sebastian M Schmid, Christoph Terkamp, Elmar Jaeckel, Katja Rohwedder, Markus F Scheerer, John Xu, Weifeng Tang, Andreas L Birkenfeld

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00673231. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 5% 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.

NCT00673231 phase3completed

A 24-week International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study With a 80-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Patients With Type 2 Diabetes With Inadequate Glycaemic Control on Insulin

Ran2008Enrolled1,240Registered outcomes6Posted comparisons15ConditionsType 2 DiabetesArmsdapagliflozin, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

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  20. Dapagliflozin Improves Erythropoiesis and Iron Metabolism in Type 2 Diabetic Patients with Renal Anemia.Diabetes, metabolic syndrome and obesity : targets and therapy · 2023
    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

10 authors at 6 institutions in 2 countries.

Jens AberleDepartment for Endocrinology and Diabetology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
Markus MenzenDivision of Internal Medicine, Department of Gastroenterology and Diabetology, Community Hospital Bonn, Bonn, Germany.
Sebastian M SchmidInstitute for Endocrinology and Diabetes, University of Lübeck, Lübeck, Germany.
Christoph TerkampDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
Elmar JaeckelDepartment of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
Katja RohwedderAstraZeneca GmbH, Wedel, Germany.
Markus F ScheererAstraZeneca GmbH, Wedel, Germany.
John XuAstraZeneca, Gaithersburg, MD, USA.
Weifeng TangAstraZeneca, Gaithersburg, MD, USA.
Andreas L BirkenfeldGerman Centre for Diabetes Research (DZD e.V.), Neuherberg, Germany. Andreas.Birkenfeld@med.uni-tuebingen.de.
AstraZeneca (Germany) · DEAstraZeneca (United States) · USGerman Center for Diabetes Research · DEMedizinische Hochschule Hannover · DEUniversity Hospital Bonn · DEUniversity Medical Center Hamburg-Eppendorf · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recent studies have shown that high-risk patients with type 2 diabetes mellitus (T2DM) treated with sodium glucose cotransporter 2 (SGLT2) inhibitors have improved cardiovascular (CV) outcomes. In an exploratory analysis of data from the EMPA-REG study, elevations in haematocrit were shown to be strongly associated with beneficial CV effects. As insulin treatment has been shown to be antinatriuretic, with an associated increase in extracellular fluid volume, it is important to confirm whether haematocrit increase is maintained with concomitant insulin therapy. Here, we investigate the effect of the SGLT2 inhibitor dapagliflozin on haematocrit, red blood cell (RBC) counts and reticulocyte levels in high-risk patients with T2DM receiving insulin. A 24-week, double-blinded, randomised, placebo-controlled trial (ClinicalTrials.gov: NCT00673231) was reported previously with extension periods of 24 and 56 weeks (total of 104 weeks). Patients receiving insulin were randomised 1:1:1:1 to placebo or dapagliflozin at 2.5, 5 or 10 mg. Haematocrit, RBC and reticulocyte measurements were conducted during this study, and a longitudinal repeated-measures analysis was performed here to examine change from baseline during treatment. Dapagliflozin treatment in combination with insulin resulted in a dose-dependent increase in haematocrit levels and RBCs over a 104 week period. There was a short-term increase in reticulocyte levels at the start of treatment, which dropped to below baseline after 8 weeks. SGLT2 inhibition with dapagliflozin leads to a sustained increase in haematocrit in patients receiving chronic insulin treatment.

Indexed as

AdolescentAdultAgedAged, 80 and overBenzhydryl CompoundsDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlucosidesHematocritHumansInsulinMaleMiddle AgedReticulocyte CountBenzhydryl CompoundsdapagliflozinGlucosidesInsulin

Identifiers

PMID33372185
PMCPMC7769973
OpenAlexW3114988689

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.