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Comparison of Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus
Plain-language guide to NCT01868529: phase 1 randomized trial of Insulin Glargine, 63 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01868529
- Phase
- phase 1
- Status
- completed
- Start
- 2008-01
- Completion (planned or actual)
- 2008-06
- Participants
- 63 (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 was conducted in Europe.
It had three arms (groups): one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
63 actual participants took part.
It was open to people of any sex aged from 18 years up to 69 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 1 diabetes mellitus (as diagnosed clinically) and treated with insulin for at least 12 months. Body Mass Index (BMI) between 18.0 and 28.0 kg/m\^2 (both inclusive).
The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: known or suspected allergy to trial product(s) or related products.
How the Study Was Run
The set-up was randomized, crossover and double-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.
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 2008-01 with completion listed for 2008-06.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Area under the glucose infusion rate curve (time frame: 0-24 hours in steady-state).
It also tracked 1 secondary outcome, for example Area under the serum insulin concentration curve at steady state.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Insulin Glargine in 63 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.