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Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes
Plain-language guide to NCT00590226: phase 4 randomized trial of Insulin Detemir and NPH Insulin (isophane), 130 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00590226
- Phase
- phase 4
- Status
- completed
- Start
- 2006-12
- Completion (planned or actual)
- 2008-01
- Participants
- 130 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Detemir and NPH Insulin (isophane).
It is not known; however, what is the best insulin regimen in hospitalized patients.
It had two arms (groups): detremir + aspart insulin (experimental) and NPH + regular insulin (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 130 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Males or females between the ages of 18 and 70 years admitted to a general medical service. A known history of type 2 diabetes mellitus \> 3 months, receiving any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy.
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: subjects with a history of acute hyperglycemic crises such as diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria \[63\]; history of drug or alcohol abuse within the last 2 years; mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Insulin Detemir group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Insulin Detemir study did not mask who received what.
It started in 2006-12 with completion listed for 2008-01.
It ran at 2 sites in United States (2).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Mean AM BG (mg/dl) (time frame: during hospitalization).
It also tracked 1 secondary outcome, for example Number of Patients With Hypoglycemic Events.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 130 people.
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 and the NPH Insulin (isophane) compound page, all human trials.
Our Notes on the Compounds
Insulin Detemir: A long-acting basal insulin analog sold as Levemir.
NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).
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.