Evidence map›Paper›PMID 28667381›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2017

Differential Treatment Response to Insulin Intensification Therapy: A Post Hoc Analysis of a Randomized Trial Comparing Premixed and Basal-Bolus Insulin Regimens.

Li Xin Shi, Peng Fei Li, Jia Ning Hou

Registry-linked trialAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00110370 (A Comparison of Prandial Insulin Lispro Mixtures Therapy to Glargine Basal-Bolus Therapy With Insulin Lispro on the Overall Glycemic Control of Patients With Type 2 Diabetes Previously Treated With Oral Agents Combined With Insulin Glargine), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT00110370 phase4completednot on this map

A Comparison of Prandial Insulin Lispro Mixtures Therapy to Glargine Basal-Bolus Therapy With Insulin Lispro on the Overall Glycemic Control of Patients With Type 2 Diabetes Previously Treated With Oral Agents Combined With Insulin Glargine

TypeinterventionalSponsorEli Lilly and CompanyRan2004 to 2006Enrolled300ConditionsDiabetes Mellitus, Type 2ArmsLispro Mixture Therapy, Glargine Basal-Bolus Therapy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. EADSG Guidelines: Insulin Therapy in Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018
    Article
  3. Article
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

3 authors.

Li Xin ShiDepartment of Endocrinology and Metabolism, Affiliated Hospital of Guiyang Medical College, Guiyang, 550004, China.
Peng Fei LiMedical Department, Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, 200021, China.
Jia Ning HouMedical Department, Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, 200021, China. hou_jia_ning@lilly.com.ORCID http://orcid.org/0000-0002-7210-0110

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIdentification of subgroups of patients that may benefit most from certain treatment is important because individual treatment response varies due to multiple contributing factors. The present study used the subgroup identification based on the differential effect search (SIDES) algorithm to identify subgroups with different treatment responses to insulin intensification therapies.

methodsThis was a post hoc analysis of a 24-week, multicenter, open-label, randomized, parallel study comparing prandial premixed therapy (PPT) to basal-bolus therapy (BBT). Patients with type 2 diabetes mellitus were randomized to PPT (insulin lispro mix 50/50 thrice daily with meals) or BBT (glargine at bedtime plus mealtime insulin lispro) insulin intensification therapies. The SIDES algorithm was used to identify the subgroups from at-goal patients [glycated hemoglobin (HbA1c) <7.0% (53.0 mmol/mol) at the end of 24 weeks; n = 182] who could have benefitted from insulin intensification therapies.

resultsBaseline characteristics of overall at-goal patients were comparable between PPT and BBT groups. The SIDES algorithm identified patients with race other than Caucasian (i.e., African-American, Asian, and Hispanic) and baseline fasting blood glucose (FBG) <8.89 mmol/L as a subgroup that could respond better to PPT relative to BBT than the overall at-goal patient population. In this identified subgroup population, the HbA1c mean (standard deviation) changes from baseline to endpoint in PPT and BBT groups were -2.27 (0.88)% versus -2.05 (0.75)%; p = 0.40, respectively; while in the overall at-goal patients, the HbA1c changes were -2.17 (0.79)% versus -2.34 (1.00)%; p = 0.19, respectively.

conclusionsThe preliminary results showed that the subgroup of patients with race other than Caucasian and FBG <8.89 mmol/L may respond better to premixed intensification therapy. This result provides some preliminary information for further investigation in prospective studies.

fundingEli Lilly and Company. CLINICAL

trial registrationClinicaltrials.gov ID number: NCT00110370.

Indexed as

Basal-bolusDifferential treatment responsePremixed insulinSIDES algorithmType 2 diabetes mellitus

Identifiers

PMID28667381
PMCPMC5544622

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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 OpenQuestion graph.