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A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus
Plain-language guide to NCT01835431: phase 3 randomized trial of Insulin Aspart and Insulin Detemir, 362 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01835431
- Phase
- phase 3
- Status
- completed
- Start
- 2013-10-17
- Completion (planned or actual)
- 2014-11-07
- Participants
- 362 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Insulin Aspart and Insulin Detemir.
This trial is conducted in Asia, Europe and North and South America.
It had two arms (groups): Insulin degludec/insulin aspart (experimental) and Insulin detemir (active comparator).
The registry classes the interventions as drug.
Who Took Part
362 actual participants took part.
It was open to people of any sex aged from 1 Year up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 0 inclusion and 1 exclusion criteria.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.
The Insulin Aspart group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.
It started in 2013-10-17 with completion listed for 2014-11-07.
It ran at 73 sites in United States (24), India (6), Israel (6), Canada (5), Russia (5) and Spain (5).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) (time frame: Week 0 to week 16).
It also tracked 6 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose, Incidence of Treatment Emergent Adverse Events (TEAEs) and Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 362 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Insulin Aspart compound page and the Insulin Detemir compound page, all human trials.
Our Notes on the Compounds
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
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.