Evidence mapPaperPMID 28817342Full record

Trial reportDiabetes technology & therapeutics2017

Hypoglycemia Risk Related to Double Dose Is Markedly Reduced with Basal Insulin Peglispro Versus Insulin Glargine in Patients with Type 2 Diabetes Mellitus in a Randomized Trial: IMAGINE 8.

Cynthia Harris, Thomas Forst, Tim Heise, Leona Plum-Mörschel, Elaine Watkins, Qianyi Zhang, Ludi Fan, Parag Garhyan, Niels Porksen

Open access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes technology & therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 43% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Insulin Therapy for the Management of Diabetes Mellitus: A Narrative Review of Innovative Treatment Strategies.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Review
  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

9 authors at 3 institutions in 2 countries.

Cynthia Harris1 Eli Lilly and Company , Indianapolis, Indiana, USA .
Thomas Forst2 Profil, Neuss, Germany .
Tim Heise2 Profil, Neuss, Germany .
Leona Plum-Mörschel3 Profil, Mainz, Germany .
Elaine Watkins4 Profil Institute for Clinical Research , Chula Vista, California, USA .
Qianyi Zhang1 Eli Lilly and Company , Indianapolis, Indiana, USA .
Ludi Fan1 Eli Lilly and Company , Indianapolis, Indiana, USA .
Parag Garhyan1 Eli Lilly and Company , Indianapolis, Indiana, USA .
Niels Porksen1 Eli Lilly and Company , Indianapolis, Indiana, USA .
Eli Lilly (United States) · USProfil Institute for Metabolic Research · DEProfil Institute for Clinical Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBasal insulin peglispro (BIL) has a peripheral-to-hepatic distribution of action that resembles endogenous insulin and a prolonged duration of action with a flat pharmacokinetic/pharmacodynamic profile at steady state, characteristics that tend to reduce hypoglycemia risk compared to insulin glargine (GL). The primary objective was to demonstrate that clinically significant hypoglycemia (blood glucose ≤54 mg/dL [3.0 mmol/L] or symptoms of severe hypoglycemia) occurred less frequently within 84 h after a double dose (DD) of BIL than a DD of GL.

methodsThis was a randomized, double-blind, two-period crossover study in patients with type 2 diabetes (T2D) previously treated with insulin (N = 68). For the first 3 weeks of each of the two crossover periods, patients received an individualized dose of BIL or GL once nightly (stable dose for 2 weeks/period). Then, during a 7-day inpatient stay with frequent blood glucose monitoring and standardized meals, one DD of study insulin was given. Glucose was infused if blood glucose was ≤54 mg/dL (3.0 mmol/L) or for symptoms of severe hypoglycemia.

resultsWithin 84 h after the DD, a significantly smaller proportion of patients experienced clinically significant hypoglycemia with BIL compared to GL (BIL, 6.6%; GL, 35.5%; odds ratio for BIL/GL 0.13 [95% confidence interval 0.04-0.39]; P < 0.001). Adverse event profiles were similar for the two insulins. Serum alanine aminotransferase and triglyceride levels were significantly higher with BIL versus GL.

conclusionsBIL has a markedly lower risk of hypoglycemia than GL when replicating a double-dose error in patients with T2D.

Indexed as

AdolescentAdultAgedBlood GlucoseCross-Over StudiesDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodFemaleHumansHypoglycemiaHypoglycemic AgentsInsulin GlargineInsulin LisproMaleMiddle Agedbasal insulin peglisproBlood GlucoseHypoglycemic AgentsInsulin GlargineInsulin LisproPolyethylene GlycolsBasal insulin peglispro (BIL)Fasting blood glucoseHypoglycemiaInsulin therapy.Type 2 diabetes

Identifiers

PMID28817342
PMCPMC5567880
OpenAlexW2749532988

What Socratic holds

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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 Socratic graph.