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Basal Insulins - Pharmacodynamics
Plain-language guide to NCT00566124: phase 4 randomized trial of Insulin Glargine and Insulin Detemir, 10 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00566124
- Phase
- phase 4
- Status
- completed
- Start
- 2005-01
- Completion (planned or actual)
- 2005-05
- Participants
- 10 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Diabetes
- 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 and Insulin Detemir.
It had three arms (groups): 1 (active comparator), 2 (active comparator) and 3 (active comparator).
Insulin detemir.
Insulin glargine.
NPH insulin.
The registry classes the interventions as drug.
More on the Plan
C-peptide, insulin, NEFA and counter regulatory hormones were measured throughout the clamp period.
Endogenous glucose release (EGR) was assessed by the isotope dilution technique (3-3H-glucose).
Who Took Part
10 actual participants took part.
It was open to men only aged from 20 years up to 50 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: BMI 20 - 50 kg/m2. Blood pressure \< 140/90 mmHg. Signed informed consent.
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: alcohol or drug abuse; use of prescription drugs.
How the Study Was Run
The set-up was randomized, crossover and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.
Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.
As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2005-01 with completion listed for 2005-05.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate (time frame: 24 hours).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Detemir in 10 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 Glargine compound page and the Insulin Detemir compound page, all human trials.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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.