Evidence map›Paper›PMID 27287069›Full record

Trial reportJournal of diabetes investigation2017

Impact of diet on the efficacy of insulin lispro mix 25 and insulin lispro mix 50 as starter insulin in East Asian patients with type 2 diabetes: Subgroup analysis of the Comparison Between Low Mixed Insulin and Mid Mixed Insulin as Starter Insulin For Patients with Type 2 Diabetes Mellitus (CLASSIFY Study) randomized trial.

Wei Chen, Lei Qian, Hirotaka Watada, Peng Fei Li, Noriyuki Iwamoto, Makoto Imori, Wen Ying Yang

Open access · goldAbstract readClinical Trial, Phase IVRandomized Controlled Trial
In one paragraph

Trial report in Journal of diabetes investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.2field-weighted citation impact, top 18% 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.

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, 7 citations in OpenAlex.

  1. Trial
  2. The Effect of LM25 and LM50 on Hypoglycemia in Chinese T2DM Patients: Post Hoc Analysis of a Randomized Crossover Trial.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Article
  3. Review
  4. Article
  5. Article
  6. Use of 50/50 Premixed Insulin Analogs in Type 2 Diabetes: Systematic Review and Clinical Recommendations.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2017
    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

7 authors at 6 institutions in 3 countries.

Wei ChenDepartment of Parenteral and Enteral Nutrition, Peking Union Medical College Hospital, Beijing, China.
Lei QianMedical Department, Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.
Hirotaka WatadaDepartment of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Peng Fei LiMedical Department, Lilly Suzhou Pharmaceutical Co. Ltd, Shanghai, China.
Noriyuki IwamotoMedicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
Makoto ImoriMedicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan.
Wen Ying YangDepartment of Endocrinology, China-Japan Friendship Hospital, Beijing, China.
Eli Lilly (Japan) · JPAmerican Society for Parenteral and Enteral Nutrition · USChina-Japan Friendship Hospital · CNJuntendo University · JPLilly (China) · CNLuye Pharma (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

AIMS/

introductionThe pathophysiology of diabetes differs between Asian and Western patients in many ways, and diet is a primary contributor. The present study examined the effect of diet on the efficacy of 25% insulin lispro/75% insulin lispro protamine suspension (LM25) and 50% insulin lispro/50% insulin lispro protamine suspension (LM50) as starter insulin in Chinese and Japanese patients with type 2 diabetes and inadequate glycemic control with oral antidiabetic medication. MATERIALS AND

methodsThis was a predefined subgroup analysis of a phase 4, open-label, 26-week, parallel-arm, randomized (computer-generated random sequence) trial (21 January 2013 to 22 August 2014). Nutritional intake was assessed from food records kept by participants before study drug administration. Outcomes assessed were changes from baseline in self-monitored blood glucose, 1,5-anhydroglucitol and glycated hemoglobin.

resultsIn total, 328 participants were randomized to receive twice-daily LM25 (n = 168) or LM50 (n = 160). Median daily nutritional intake (by weight and percentage of total energy) was 230.8 g of carbohydrate (54%), 56.5 g of fat (31%) and 66 g of protein (15%). Improvements in self-monitored blood glucose were significantly greater (P ≤ 0.028) in the LM50 group than in the LM25 group, regardless of nutritional intake. When carbohydrate (by weight or percentage energy) or fat (by weight) intake exceeded median levels, LM50 was significantly more efficacious than LM25 (P ≤ 0.026) in improving 1,5-anhydroglucitol and glycated hemoglobin.

conclusionsGlycemic control improved in both LM25 and LM50 groups, but LM50 was significantly more efficacious under certain dietary conditions, particularly with increased carbohydrate intake.

Indexed as

DietAsian PeopleDiabetes Mellitus, Type 2Drug CombinationsFemaleHumansHypoglycemic AgentsInsulin LisproMaleMiddle AgedNutrition AssessmentTreatment OutcomeDrug CombinationsHypoglycemic AgentsInsulin LisproDiabetes mellitusDietInsulin lispro

Identifiers

PMID27287069
PMCPMC5217926
OpenAlexW2531488662

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.