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A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes
Plain-language guide to NCT00961324: phase 1 randomized trial of Insulin Glargine, 54 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00961324
- Phase
- phase 1
- Status
- completed
- Start
- 2009-07-27
- Completion (planned or actual)
- 2009-10-26
- Participants
- 54 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Insulin Glargine.
This trial is conducted in Europe.
The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.
It had two arms (groups): IDeg (experimental) and IGlar (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 54 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female aged 18-65 years (both inclusive). Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months. Body mass index 18.0-28.0 kg/m\^2 (both inclusive).
The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day); not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.
Those kept unaware of assignments: participant and investigator.
It started in 2009-07-27 with completion listed for 2009-10-26.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Insulin Glargine in 54 people.
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, all human trials.
Our Notes on the Compound
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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.