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Effectiveness of Adding Subcutaneous Long-Acting Detemir to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy
Plain-language guide to NCT01186003: not phased randomized trial of Insulin Detemir, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01186003
- Phase
- not phased
- Status
- completed
- Start
- 2010-08
- Completion (planned or actual)
- 2014-05
- Participants
- 30 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Insulin Detemir.
It had two arms (groups): Standard insulin drip therapy (no intervention) and Insulin drip and Detemir (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 30 actual participants took part.
It was open to people of any sex aged from 19 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diabetic ketoacidosis (DKA) and hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre-and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutritional requiring insulin drip. Patients with type 1 and type 2 diabetes mellitus (DM) will be included. Patient with both types of diabetes will be among those treated with insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition. Patients will be of age 19 to 80.
The full record lists 4 inclusion and 1 exclusion criteria.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Insulin Detemir and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Insulin Detemir study: the participants and staff both knew the treatment.
It started in 2010-08 with completion listed for 2014-05.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a not phased, 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; results are posted on the registry, and this page does not restate them.
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.