Trial reportDiabetes care2013

The efficacy and safety of imeglimin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy.

Pascale Fouqueray, Valdis Pirags, Silvio E Inzucchi, Clifford J Bailey, Guntram Schernthaner, Michaela Diamant, Harold E Lebovitz

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2013. The graph read 1 number from its abstract, feeding 2 cells of the map: it supports the treatment in 2. Cited by 44 papers, 4 of them syntheses that pooled it.

1number the graph read from it
2cells of the map it votes in
44citing papers in PubMed, 4 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.

← favours the treatmentfavours the comparator →
-0.440 · no effect
Glycemic controlfavours the treatment · against placebo · t2dfeeds 2 cells of the map
placebo-subtracted decrease -0.44P < 0.001
RESULTS: After 12 weeks, the placebo-subtracted decrease in A1C with metformin-imeglimin was -0.44% (P < 0.001).

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

SupportsOpen on the map →What to test next →

40 readable studies in this cell: 41 favour the treatment, 12 find no difference, 8 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 · 2013
placebo-subtracted decrease -0.44
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
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

Other glucose-lowering×glycemic control

SupportsOpen on the map →What to test next →

8 readable studies in this cell: 4 favour the treatment, 0 find no difference, 4 favour the comparator.

Belief with this paper
0.50contested · 3 families support, 1 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2013
placebo-subtracted decrease -0.44
NCT017093055,570 enrolled · 2012
Δ 0.190.02 to 0.36
NCT050350821,018 enrolled · 2021
Δ -0.24-0.44 to -0.04
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

44 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Pooled it
  5. Trial
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  8. Trial
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  11. Trial
  12. Article
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  16. Review
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  20. Review
6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

7 authors.

Pascale FouquerayPoxel SA, Lyon, France. pascale.fouqueray@poxelpharma.com
Valdis Pirags
Silvio E Inzucchi
Clifford J Bailey
Guntram Schernthaner
Michaela Diamant
Harold E Lebovitz

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.

objectiveA 12-week study assessed the efficacy and safety of a new oral antidiabetic agent, imeglimin, as add-on therapy in type 2 diabetes patients inadequately controlled with metformin alone. RESEARCH DESIGN AND

methodsA total of 156 patients were randomized 1:1 to receive imeglimin (1,500 mg twice a day) or placebo added to a stable dose of metformin (1,500-2,000 mg/day). Change in A1C from baseline was the primary efficacy outcome; secondary outcomes included fasting plasma glucose (FPG) and proinsulin/insulin ratio.

resultsAfter 12 weeks, the placebo-subtracted decrease in A1C with metformin-imeglimin was -0.44% (P < 0.001). Metformin-imeglimin also significantly improved FPG and the proinsulin/insulin ratio from baseline (-0.91 mg/dL and -7.5, respectively) compared with metformin-placebo (0.36 mg/dL and 11.81). Metformin-imeglimin therapy was generally well-tolerated with a comparable safety profile to metformin-placebo.

conclusionsAddition of imeglimin to metformin improved glycemic control and offers potential as a new treatment for type 2 diabetes.

Indexed as

AdolescentAdultAgedDiabetes Mellitus, Type 2FemaleHumansHypoglycemic AgentsMaleMetforminMiddle AgedTreatment OutcomeTriazinesYoung AdultHypoglycemic AgentsimegliminMetforminTriazines

Identifiers

PMID23160726
PMCPMC3579350

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
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 Socratic graph.