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Similar glucose control with basal-bolus regimen of insulin detemir plus insulin aspart and thrice-daily biphasic insulin aspart 30 in insulin-naive patients with type 2 diabetes: Results of a 50-week randomized clinical trial of stepwise insulin intensification
Plain-language guide to PMID 25483023 (2015): open-label randomized controlled trial study of Insulin Aspart and Insulin Detemir.
Key Facts
- PMID
- 25483023
- Journal
- Diabetes & metabolism
- Year
- 2015
- Study type
- Randomized Controlled Trial
- Authors
- Malek R et al. (6 authors)
- DOI
- 10.1016/j.diabet.2014.11.002
What This Study Did, in Plain Language
What Was Tested
This randomized controlled trial paper looks at Insulin Aspart and Insulin Detemir.
Who Took Part
PubMed indexes the participants as adults and middle-aged adults, both men and women.
In this open-label multicentre, multinational, randomized, parallel-arm treat-to-target trial, 403 insulin-naive patients with T2DM in four African countries were randomized to either an IDet+IAsp (n = 200) or BIAsp1-2-3 (n = 203) treatment group.
The primary endpoint was change in HbA1c after 50 weeks of treatment.
How the Study Was Run
The design is described as randomized, open-label, multicenter and parallel-group.
The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.
Being open-label, the Insulin Aspart study did not mask who received what.
More than one site took part, so the participants came from several places.
The Insulin Aspart group and the comparison group ran side by side rather than switching.
The timeline in the abstract includes 50 weeks.
Stepwise insulin intensification was performed at the end of 14, 26 and 38 weeks, depending on HbA1c values.
Safety variables were hypoglycaemia incidence, occurrence of adverse events and weight gain.
What Was Measured
PubMed files the paper under topics including Africa, Biphasic Insulins, Blood Glucose, Diabetes Mellitus, Type 2, Hypoglycemic Agents, Insulin Aspart and Insulin Detemir.
The authors tagged it with the keywords Basal–bolus insulin, Biphasic insulin aspart, Insulin intensification, Premixed insulin and Type 2 diabetes.
What This Means in Plain Language
The paper is a randomized, open-label and multicenter study of Insulin Aspart and Insulin Detemir over 50 weeks.
Its findings take up roughly 5 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.
The publication is from 2015 (Diabetes & metabolism), a journal based in France.
More context: the Insulin Aspart compound page and the Insulin Detemir compound page, all human trials.
Our Notes on the Compounds
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
Insulin Detemir: A long-acting basal insulin analog sold as Levemir.
NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).
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.