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Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial
Plain-language guide to PMID 31984443 (2020): open-label randomized controlled trial study of Insulin Glargine.
Key Facts
- PMID
- 31984443
- Journal
- Diabetologia
- Year
- 2020
- Study type
- Randomized Controlled Trial
- Authors
- Philis-Tsimikas A et al. (10 authors)
- DOI
- 10.1007/s00125-019-05080-9
- Registered trial
- NCT03078478
What This Study Did, in Plain Language
What Was Tested
Researchers studied Insulin Glargine in this randomized controlled trial publication.
Who Took Part
PubMed indexes the participants as middle-aged adults and older adults, both men and women.
Participants were previously treated with basal insulin with or without oral glucose-lowering drugs (excluding insulin secretagogues) and had to fulfil at least one predefined criterion for hypoglycaemia risk.
Endpoints were assessed during a 36 week maintenance period and a total treatment period up to 88 weeks.
How the Study Was Run
The researchers set it up as a randomized and open-label study.
Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
A time span of 36 weeks appears in the methods.
The primary endpoint was the number of overall symptomatic hypoglycaemic events in the maintenance period.
Secondary hypoglycaemia endpoints included the number of nocturnal symptomatic events and number of severe hypoglycaemic events during the maintenance period.
What Was Measured
The subject headings attached to it are Blood Glucose, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Hypoglycemia, Insulin Glargine, Insulin, Long-Acting and Risk Factors.
The authors tagged it with the keywords Clinical science, Hypoglycaemia, Insulin degludec and Insulin therapy.
What This Means in Plain Language
The paper is a randomized and open-label study of Insulin Glargine over 36 weeks.
The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.
The publication is from 2020 (Diabetologia), a journal based in Germany.
More context: the Insulin Glargine compound page.
Our Notes on the Compound
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
Related Pages
Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.