Evidence map›Metformin × glycemic control›PMID 26749407›Full record

Trial reportDiabetes, obesity & metabolism2016

Effect of ranolazine on glycaemic control in patients with type 2 diabetes treated with either glimepiride or metformin.

J Pettus, B McNabb, R H Eckel, J S Skyler, A Dhalla, S Guan, P Jochelson, L Belardinelli, R H Henry

Erratum issuedAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2016. The graph read 1 number from its abstract, feeding 1 cell of the map: it finds no clear difference in 1. An erratum has been issued. Cited by 4 papers.

1number the graph read from it
1cell of the map it votes in
4citing papers in PubMed
2.7field-weighted citation impact, top 10% 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.

← favours the treatmentfavours the comparator →
-0.310.100 · no effect
Glycemic controlno clear difference · against placebo · ascvd, t2dfeeds one cell of the map
Δ -0.11-0.31 to 0.10
When added to metformin background therapy, there was no significant difference in the 24-week HbA1c change from baseline [placebo-corrected LS mean difference -0.11% (95% CI -0.31, 0.1)].
FeedsMetformin×glycemic control

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Metformin×glycemic control

InconclusiveOpen on the map →What to test next →

40 readable studies in this cell: 41 favour the treatment, 13 find no difference, 7 favour the comparator.

Belief with this paper
0.84replicated · 32 families support, 6 contradict · against placebo
Without it
0.84This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2016
Δ -0.11-0.31 to 0.10
NCT017190031,413 enrolled · 2012
Adjusted mean -0.72-0.95 to -0.48
NCT018093271,186 enrolled · 2013
Δ -0.40-0.59 to -0.21
NCT022730501,136 enrolled · 2014
Δ -0.89-1.08 to -0.69
NCT008598981,093 enrolled · 2009
Δ -0.53-0.74 to -0.32
The study to understand the genetics of the acute response to metformi…PMID 25812009 · 1,033 enrolled · 2008
Δ -0.85-43.8 to 26.7
NCT00643851994 enrolled · 2008
Δ -0.86-1.11 to -0.62
NCT01708902876 enrolled · 2012
Δ -1.00-1.23 to -0.78
NCT00676338820 enrolled · 2008
Δ -0.05-0.26 to 0.17
NCT01126580807 enrolled · 2010
Δ -0.22-0.36 to -0.08
NCT01023581784 enrolled · 2009
Δ -0.67-0.96 to -0.37
NCT01076088744 enrolled · 2010
Δ -0.84-1.15 to -0.52
NCT00386100688 enrolled · 2006
Δ -0.49-0.67 to -0.30
4 · 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.

5 · Its place in the literature

Who cites it

4 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Ranolazine: Multifaceted Role beyond Coronary Artery Disease, a Recent Perspective.Heart views : the official journal of the Gulf Heart Association
    Review
6 · The record

Corrections and comments

7 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

J PettusDepartment of Medicine, Division of Endocrinology, University of California San Diego, San Diego, CA, USA.
B McNabbGilead Pharmaceuticals, Foster City, CA, USA.
R H EckelDepartment of Medicine, Division of Endocrinology, University of California San Diego, San Diego, CA, USA.
J S SkylerDepartment of Medicine, Division of Endocrinology, University of California San Diego, San Diego, CA, USA.
A DhallaGilead Pharmaceuticals, Foster City, CA, USA.
S GuanGilead Pharmaceuticals, Foster City, CA, USA.
P JochelsonGilead Pharmaceuticals, Foster City, CA, USA.
L BelardinelliGilead Pharmaceuticals, Foster City, CA, USA.
R H HenryDepartment of Medicine, Division of Endocrinology, University of California San Diego, San Diego, CA, USA.
Gilead Sciences (United States) · USUniversity of California, San Diego · USUniversity of San Diego · US

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

aimTo report the results of two phase III trials assessing the efficacy of ranolazine for glycaemic control in patients with type 2 diabetes on metformin or glimepiride background therapy.

methodsIn two double-blind trials we randomized 431 and 442 patients with type 2 diabetes to ranolazine 1000 mg twice daily versus placebo added to either glimepiride (glimepiride add-on study) or metformin background therapy (metformin add-on study). Patients receiving ranolazine added to metformin had their metformin dose halved (with the addition of a metformin-matched placebo) relative to the placebo group to correct for a metformin-ranolazine pharmacokinetic interaction. The primary endpoint of the trials was the change from baseline in glycated haemoglobin (HbA1c) at week 24.

resultsWhen added to glimepiride, ranolazine caused a 0.51% least squares mean [95% confidence interval (CI) 0.71, 0.32] decrease from baseline in HbA1c at 24 weeks relative to placebo and roughly doubled the proportion of patients achieving an HbA1c of <7% (27.1 vs 14.1%; p = 0.001). When added to metformin background therapy, there was no significant difference in the 24-week HbA1c change from baseline [placebo-corrected LS mean difference -0.11% (95% CI -0.31, 0.1)].

conclusionsCompared with placebo, addition of ranolazine in patients with type 2 diabetes treated with glimepiride, but not metformin, significantly reduced HbA1c over 24 weeks. The decreased dose of metformin used in the metformin add-on study complicates the interpretation of this trial. Whether an effective regimen of ranolazine added to metformin for glycaemic control can be identified remains unclear.

Indexed as

AgedCardiovascular DiseasesDiabetes Mellitus, Type 2Double-Blind MethodDrug InteractionsDrug MonitoringDrug ResistanceDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsMaleMetforminglimepirideGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetforminRanolazineSodium Channel BlockersSulfonylurea Compoundsantidiabetic drugclinical trialglycaemic controlrandomized trialtype 2 diabetes

Identifiers

PMID26749407
OpenAlexW2223445978

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.