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A Trial to Investigate Efficacy and Usability of Published Best Practice to Control Glycaemia
Plain-language guide to NCT01407289: phase 4 non-randomized trial of Insulin Glargine and Insulin Aspart, 74 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01407289
- Phase
- phase 4
- Status
- completed
- Start
- 2011-06
- Completion (planned or actual)
- 2012-04
- Participants
- 74 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Insulin Glargine and Insulin Aspart.
It had two arms (groups): Insulin titration protocol (experimental) and Standard care (no intervention).
Patients in care at the Division of Endocrinology will be treated by enhanced version of published best paper based practice insulin titration protocol to control glycaemia in hospitalised patients with type 2 diabetes.
Patients in care of the Division of Cardiology will be treated using antihyperglycaemic therapy according to standard care.
The registry classes the interventions as drug.
Who Took Part
The registry lists 74 actual participants took part.
It was open to people of any sex aged from 18 years up to 90 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes. Expected stay ≥ 48 hours.
The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: hyperglycemia without known history of type 2 diabetes mellitus; clinically relevant hepatic disease.
How the Study Was Run
The set-up was non-randomized, parallel-group and open-label.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2011-06 with completion listed for 2012-04.
It ran at 1 site in Austria.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Mean blood glucose (time frame: duration of hospital stay (48 hours - maximum three weeks)).
It also tracked 1 secondary outcome, for example Number of glucose measurements in hyperglycaemic ranges.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Insulin Glargine and Insulin Aspart in 74 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Glargine compound page and the Insulin Aspart compound page, all human trials.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.