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Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care
Plain-language guide to NCT00950534: phase 4 randomized trial of Insulin Glargine, 25 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00950534
- Phase
- phase 4
- Status
- terminated early
- Start
- 2009-07
- Completion (planned or actual)
- 2010-08
- Participants
- 25 (actual)
- Design
- 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.
It had two arms (groups): General Practitioner initiation with insulin glargine (experimental) and Usual standard of care (active comparator).
Patients will be prescribed insulin glargine by their Investigator and they will be taught how to administer insulin glargine according to Australian guidelines. Patients will be treated for 24 weeks.
The registry classes the interventions as drug.
Who Took Part
The registry lists 25 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diagnosed with type 2 Diabetes Mellitus (T2DM). Willing and able to perform blood glucose monitoring using a blood glucose meter. Willing and able to keep a daily patient diary. Willing and able to provide written informed consent before enrolment in the study.
The full record lists 6 inclusion and 21 exclusion criteria; among the exclusions: type 1 diabetes mellitus; body mass index (bmi) \> 45 kg/m²; works night shifts.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
Being open-label, the Insulin Glargine study did not mask who received what.
It started in 2009-07 with completion listed for 2010-08.
It ran at 1 site in Australia.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 5 secondary outcomes, for example Mean change in body weight.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 25 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Glargine compound page, all human trials.
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: 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.