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A Comparison of Two Initial Dosing Formulas
Plain-language guide to NCT01377155: not phased randomized trial of Insulin Detemir, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01377155
- Phase
- not phased
- Status
- completed
- Start
- 2011-06
- Completion (planned or actual)
- 2011-12
- Participants
- 20 (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
This registered not phased trial tested Insulin Detemir.
This study will evaluate two methods of starting basal insulin to see which method may achieve a faster-to-goal titration.
It had 1 arm (groups): Insulin determir (other).
The registry classes the interventions as drug.
Who Took Part
The registry lists 20 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: Age 18 years and above. Concurrently on ± sulfonylureas ± thiazolidinedione ± DDP IV inhibitors ± metformin ± glinides. Capable of self monitoring glucose ≥4/day. Previously compliant with clinical recommendations. BMI ≤ 45 kg/m2.
The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: urinary ketosis; currently participating in another clinical trial; known or suspected allergy to insulin determir.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Insulin Detemir group and the comparison group should start out alike.
The Insulin Detemir group and the comparison group ran side by side rather than switching.
Everyone knew when Insulin Detemir 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 2011-12.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Days to reach the titration target (time frame: 12 weeks).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Insulin Detemir in 20 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.