Evidence map›Paper›PMID 24988185›Full record

ArticleCPT: pharmacometrics & systems pharmacology2014

Methods for Predicting Diabetes Phase III Efficacy Outcome From Early Data: Superior Performance Obtained Using Longitudinal Approaches.

J B Møller, N R Kristensen, S Klim, M O Karlsson, S H Ingwersen, M C Kjellsson

Erratum issuedAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

J B MøllerQuantitative Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
N R KristensenQuantitative Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
S KlimQuantitative Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
M O KarlssonThe Pharmacometrics Group, Uppsala University, Uppsala, Sweden.
S H IngwersenQuantitative Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.
M C KjellssonThe Pharmacometrics Group, Uppsala University, Uppsala, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The link between glucose and HbA1c at steady state has previously been described using steady-state or longitudinal relationships. We evaluated five published methods for prediction of HbA1c after 26/28 weeks using data from four clinical trials. Methods (1) and (2): steady-state regression of HbA1c on fasting plasma glucose and mean plasma glucose, respectively, (3) an indirect response model of fasting plasma glucose effects on HbA1c, (4) model of glycosylation of red blood cells, and (5) coupled indirect response model for mean plasma glucose and HbA1c. Absolute mean prediction errors were 0.61, 0.38, 0.55, 0.37, and 0.15% points, respectively, for Methods 1 through 5. This indicates that predictions improved by using mean plasma glucose instead of fasting plasma glucose, by inclusion of longitudinal glucose data and further by inclusion of longitudinal HbA1c data until 12 weeks. For prediction of trial outcome, the longitudinal models based on mean plasma glucose (Methods 4 and 5) had substantially better performance compared with the other methods.

Identifiers

PMID24988185
PMCPMC4120014

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Registered trials

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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.