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Efficacy and Safety of Insulin Detemir in Type 1 Diabetes
Plain-language guide to NCT00595374: phase 3 randomized trial of Insulin Aspart and Insulin Detemir, 114 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00595374
- Phase
- phase 3
- Status
- completed
- Start
- 2003-12-02
- Completion (planned or actual)
- 2004-10-07
- Participants
- 114 (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 Europe.
The registry classes the interventions as drug.
Who Took Part
The registry lists 114 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: Duration of type 1 diabetes for at least 12 months. BMI below 35 kg/m2. Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months. Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator.
The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: known or suspected allergy to trial product or related products; previous participation in this trial; receipt of any investigational products within the last 2 months prior to this trial.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.
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 2003-12-02 with completion listed for 2004-10-07.
It ran at 18 sites in Netherlands (18).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: HbA1c (time frame: after 26 weeks of treatment).
It also tracked 5 secondary outcomes, for example Plasma glucose profiles, Change in body weight, Quality of Life, Incidence of adverse events and Incidence of hypoglycaemic episodes.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 114 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.