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Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
Plain-language guide to NCT01709929: phase 3 non-randomized trial of Insulin Detemir, 2287 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01709929
- Phase
- phase 3
- Status
- completed
- Start
- 2005-10
- Completion (planned or actual)
- 2006-04
- Participants
- 2287 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Insulin Detemir.
This trial is conducted in North America.
The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.
It had 1 arm (groups): Insulin detemir (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 2287 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Diagnosed with type 1 or type 2 diabetes. Using a basal/bolus insulin regimen.
The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit; subjects who previously enrolled in this study; subjects with a hypersensitivity to insulin detemir or to any of the excipients.
How the Study Was Run
The set-up was non-randomized, single-group and open-label.
Nothing was hidden in this open-label Insulin Detemir study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2005-10 with completion listed for 2006-04.
It ran at 1 site in Canada.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events.
It also tracked 5 secondary outcomes, for example Number of adverse events (all and serious), Number of all hypoglycaemic events, Change in weight, HbA1c (glycosylated haemoglobin) and Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22).
What This Means in Plain Language
Put simply, this is a phase 3, non-randomized trial of Insulin Detemir in 2287 people.
With 2287 participants it is a large trial for this field.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Detemir compound page, all human trials.
Our Notes on the Compound
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.