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A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
Plain-language guide to NCT01809184: phase 1 randomized trial of Insulin Glargine, 84 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01809184
- Phase
- phase 1
- Status
- completed
- Start
- 2013-03-04
- Completion (planned or actual)
- 2013-09-06
- Participants
- 84 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- 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.
It had seven arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
84 actual participants took part.
It was open to men only aged from 18 years up to 55 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Body mass index 18.0-28.0 kg/m\^2.
The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial products or related products; previous participation in this trial. participation is defined as randomised; any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant and investigator.
It started in 2013-03-04 with completion listed for 2013-09-06.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Number of adverse events (AEs).
It also tracked 2 secondary outcomes, for example Area under the serum insulin concentration-time curve and Area under the glucose infusion rate (GIR)-time curve.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Insulin Glargine in 84 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.