← Human Trials & Peer-Reviewed Studies
Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes
Plain-language guide to NCT01697657: phase 3 randomized trial of Insulin Aspart and Insulin Detemir, 131 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01697657
- Phase
- phase 3
- Status
- completed
- Start
- 2001-09
- Completion (planned or actual)
- 2002-11
- Participants
- 131 (actual)
- Design
- randomized, open label (everyone knows who gets what), 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 3) is built around Insulin Aspart and Insulin Detemir.
This trial is conducted in Africa, Europe and Oceania.
It had two arms (groups): Detemir (experimental) and NPH (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 131 actual participants took part.
It was open to people of any sex aged from 18 years up to 100 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 1 diabetes. Fasting c-peptide below lower limit of normal fasting range. Duration of type 1 diabetes for at least 12 months. Able and willing to perform self-monitoring of blood glucose. BMI (body Mass Index) maximum 35 kg/m\^2.
The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: proliferative retinopathy or maculopathy requiring acute treatment; known unawareness of hypoglycaemia; impaired hepatic function.
How the Study Was Run
The set-up was randomized, crossover and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.
In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.
Being open-label, the Insulin Aspart study did not mask who received what.
It started in 2001-09 with completion listed for 2002-11.
It ran at 11 sites in Australia (3), Denmark (2), Italy (2), Sweden (2), Croatia (1) and South Africa (1).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Incidence of total self-recorded hypoglycaemic episodes.
It also tracked 7 secondary outcomes, for example Incidence of total major hypoglycaemic episodes, HbA1c (glycosylated haemoglobin), 8-point plasma glucose profiles, Serum glucose profiles, 72-hours glucose profile and Within-subject variation in home-measured fasting plasma glucose.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 131 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
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.
NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).
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.