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Detemir Energy Expenditure Study
Plain-language guide to NCT00788840: phase 4 randomized trial of Insulin Detemir, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00788840
- Phase
- phase 4
- Status
- completed
- Start
- 2008-01
- Completion (planned or actual)
- 2009-08
- Participants
- 30 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Detemir.
This is a study designed to compare the effects of 2 long-acting insulins, detemir and insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic control and fat and muscle gene expression over a 6 month period.
It had two arms (groups): 1. Insulatard (active comparator) and 2. Detemir (active comparator).
The registry classes the interventions as drug.
Who Took Part
30 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes. Treated with metformin. Already on treatment with a long-acting or intermediate insulin. Over 18 years of age,. Able and willing to perform self-blood glucose monitoring.
The full record lists 9 inclusion and 6 exclusion criteria; among the exclusions: patients on sulphonylureas or thiazolidinediones; proliferative retinopathy that has required acute treatment within the last six months; impaired hepatic or renal functions.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin Detemir and who got the comparison, which limits bias.
The Insulin Detemir group and the comparison group ran side by side rather than switching.
Being open-label, the Insulin Detemir study did not mask who received what.
It started in 2008-01 with completion listed for 2009-08.
It ran at 1 site in United Kingdom.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Weight change (time frame: 6 months).
It also tracked 4 secondary outcomes, for example Energy Expenditure, Fat composition, Fat & muscle gene expression and Glycaemic control.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Detemir in 30 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Detemir compound page, all human trials.
Our Notes on the Compound
Insulin Detemir: A long-acting basal insulin analog sold as Levemir.
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.