Evidence map›Paper›PMID 32052516›Full record

Trial reportDiabetes, obesity & metabolism2020

Efficacy and safety of dual add-on therapy with dapagliflozin plus saxagliptin versus glimepiride in patients with poorly controlled type 2 diabetes on a stable dose of metformin: Results from a 52-week, randomized, active-controlled trial.

Juan P Frias, Guillermo Gonzalez-Galvez, Eva Johnsson, Jill Maaske, Marcia A Testa, Donald C Simonson, Nalina Dronamraju, Ricardo Garcia-Sanchez, Anne L Peters

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02419612. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 29% 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.

NCT02419612 phase3completed

A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin ≥1500 mg in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Ran2015Enrolled444Registered outcomes8Posted comparisons8ConditionsDiabetesArmsdapagliflozin, Glimepiride, Placebo, Saxagliptin
Open the trial in the graph
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Review
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

9 authors at 7 institutions in 7 countries.

Juan P FriasNational Research Institute, Los Angeles, California.ORCID 0000-0001-9486-1255
Guillermo Gonzalez-GalvezJalisco Institute of Diabetes and Obesity Research, Guadalajara, Mexico.
Eva JohnssonBioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Jill MaaskeBioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.
Marcia A TestaHarvard T.H. Chan School of Public Health, Boston, Massachusetts.
Donald C SimonsonDivision of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Boston, Massachusetts.ORCID 0000-0002-4670-6290
Nalina DronamrajuBioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Ricardo Garcia-SanchezBioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.
Anne L PetersKeck School of Medicine of the University of Southern California, Los Angeles, California.ORCID 0000-0003-0520-0776
AstraZeneca (Australia) · AUAstraZeneca (Finland) · FIBrigham and Women's Hospital · USHarvard University · USNational Research Institute · USSecretaría de Salud de Jalisco · MXUniversity of Southern California · US

Funding

American Diabetes AssociationAstraZeneca
6 · The paper itself

Abstract

aimsTo evaluate the efficacy and safety of dapagliflozin (DAPA) + saxagliptin (SAXA) compared with glimepiride (GLIM) in patients with type 2 diabetes who were inadequately controlled [glycated haemoglobin (HbA1c) 7.5-10.5% (58-91 mmol/mol)] on metformin monotherapy. MATERIALS AND

methodsThis 52-week, multicentre, double-blind, active-controlled study (NCT02419612) randomized (1:1) patients on metformin to add-on DAPA 10 mg + SAXA 5 mg (n = 227) or GLIM 1-6 mg (titrated; n = 217). The primary efficacy endpoint was change in HbA1c from baseline to week 52.

resultsBaseline mean ± standard deviation of age, duration of diabetes and HbA1c were 56.1 ± 9.7 years, 7.8 ± 6.4 years and 8.5% ± 0.8% (69 ± 9.0 mmol/mol), respectively. Adjusted mean change from baseline in HbA1c was -1.35% (-14.8 mmol/mol) with DAPA + SAXA versus -0.98% (-10.7 mmol/mol) with GLIM (P <0.001). Changes from baseline in body weight and systolic blood pressure were -3.1 kg and -2.6 mmHg with DAPA + SAXA versus +1.0 kg (P <0.001) and +1.0 mmHg (P = 0.007) with GLIM. More patients achieved HbA1c <7.0% (53 mmol/mol) (44.3% vs. 34.3%; P = 0.044), and fewer patients required treatment intensification (1.3% vs. 8.8%; P = 0.002) with DAPA + SAXA than with GLIM.

conclusionsCompared with GLIM, concurrent addition of DAPA + SAXA significantly improved glycaemic control, body weight and other metabolic parameters in patients inadequately controlled on metformin. Trial: NCT02419612, ClinicalTrials.gov.

Indexed as

Diabetes Mellitus, Type 2HypoglycemiaMetforminAdamantaneAgedBenzhydryl CompoundsBlood GlucoseDipeptidesDouble-Blind MethodDrug Therapy, CombinationGlucosidesGlycated HemoglobinHumansHypoglycemic AgentsMiddle AgedSulfonylurea CompoundsAdamantaneBenzhydryl CompoundsBlood GlucosedapagliflozinDipeptidesglimepirideGlucosidesGlycated HemoglobinHypoglycemic AgentsMetforminsaxagliptinSulfonylurea Compoundsdapagliflozinglimepirideglycaemic controlintensificationmetforminsaxagliptin

Identifiers

PMID32052516
PMCPMC7317565
OpenAlexW3006085306

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
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.