Evidence map›Paper›PMID 23906445›Full record

Trial reportDiabetes, obesity & metabolism2014

Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin.

J Bolinder, Ö Ljunggren, L Johansson, J Wilding, A M Langkilde, C D Sjöström, J Sugg, S Parikh

4 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00855166. Cited by 223 papers, 30 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
223citing papers in PubMed, 30 pooled it
–field-weighted citation impact
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.

NCT00855166 phase3completed

A 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-Controlled,Phase III Study With a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

Ran2009Enrolled182Registered outcomes7Posted comparisons7ConditionsType 2 Diabetes MellitusArmsdapagliflozin, Metformin, Placebo, Sitagliptin
Open the trial in the graph
NCT02113241 phase2 / phase3completed

Effect of Dapagliflozin Administration on Metabolic Syndrome, Insulin Sensitivity, and Insulin Secretion

Ran2014Enrolled24Registered outcomes24Posted comparisons48ConditionsMetabolic Syndrome XArmsdapagliflozin, Placebo
PMID 24463448PMID 22238392PMID 24105299PMID 24130972PMID 23910664PMID 23668478PMID 23210765PMID 23194084PMID 22701099PMID 22446170PMID 20566676PMID 20518806other papers from this trial
Open the trial in the graph
NCT03076112 phase3completednot on this mapstarted 2017, after this paper: background citation

Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin

TypeinterventionalSponsorSeoul National University Bundang HospitalRan2017 to 2022Enrolled170ConditionsType 2 Diabetes MellitusArmsIpragliflozin, Sitagliptin
NCT07342764 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Dapagliflozin Versus Metformin for the Management of Antipsychotic-Induced Weight Gain: A Pragmatic Pilot Randomized Controlled Trial

TypeinterventionalSponsorSultan Qaboos UniversityRan2026 to 2028Enrolled110ConditionsAntipsychotic-induced Weight Gain (AIWG), Antipsychotic-induced Weight GainArmsDapagliflozin, Metformin, Common Lifestyle Program
3 · Its place in the literature

Who cites it

223 citing papers in PubMed, 30 syntheses or guidelines pooled it.

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  7. Effect of SGLT2 inhibitors on fractures, BMD, and bone metabolism markers in patients with type 2 diabetes mellitus: a systematic review and meta-analysis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2023
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  20. Risk of fracture with dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, or sodium-glucose cotransporter-2 inhibitors in real-world use: systematic review and meta-analysis of observational studies.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
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163 more citing papers are in PubMed but not listed here.

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

8 authors.

J BolinderDepartment of Endocrinology, Metabolism and Diabetes, Karolinska University Hospital Huddinge, Karolinska Institute, Stockholm, Sweden.
Ö Ljunggren
L Johansson
J Wilding
A M Langkilde
C D Sjöström
J Sugg
S Parikh

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsDapagliflozin, a highly selective inhibitor of sodium-glucose cotransporter 2 (SGLT2), reduces hyperglycaemia and weight in patients with type 2 diabetes mellitus (T2DM) by increasing urinary glucose excretion. Long-term glycaemic control, body composition and bone safety were evaluated in patients with T2DM after 102 weeks of dapagliflozin treatment.

methodsThis randomized, double-blind, placebo-controlled study (NCT00855166) enrolled patients with T2DM [mean: age 60.7 years; HbA1c 7.2%; body mass index (BMI) 31.9 kg/m(2) ; body weight 91.5 kg] inadequately controlled on metformin. Patients (N = 182) were randomly assigned 1 : 1 to receive dapagliflozin 10 mg/day or placebo added to open-label metformin for a 24-week double-blind treatment period followed by a 78-week site- and patient-blinded extension period. At week 102, changes from baseline in HbA1c, weight, waist circumference, total body fat mass as measured by dual-energy X-ray absorptiometry (DXA), serum markers of bone turnover, bone mineral density (BMD) as measured by DXA, and adverse events were evaluated.

resultsA total of 140 patients (76.9%) completed the study. Over 102 weeks, dapagliflozin-treated patients showed reductions in HbA1c by -0.3%, weight by -4.54 kg, waist circumference by -5.0 cm and fat mass by -2.80 kg without increase in rate of hypoglycaemia. Compared with placebo, no meaningful changes from baseline in markers of bone turnover or BMD were identified over 102 weeks. One fracture occurred in each treatment group. The frequency of urinary tract infection (UTI) and genital infection was similar in both treatment groups.

conclusionsOver 102 weeks, dapagliflozin improved glycaemic control, and reduced weight and fat mass, without affecting markers of bone turnover or BMD in patients with T2DM inadequately controlled on metformin.

Indexed as

Sodium-Glucose Transporter 2 InhibitorsAbsorptiometry, PhotonBenzhydryl CompoundsBlood GlucoseBody Mass IndexBone DensityDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlucosidesGlycated HemoglobinHumansMaleMetforminSodium-Glucose Transporter 2Treatment OutcomeBenzhydryl CompoundsBlood GlucosedapagliflozinGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanMetforminSLC5A2 protein, humanSodium-Glucose Transporter 2Sodium-Glucose Transporter 2 Inhibitorsadipose tissuebone mineral densityfatmetforminrandomized trialSGLT2 inhibitortype 2 diabetes

Identifiers

PMID23906445

What Socratic holds

Texttitle and abstract
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.