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Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes
Plain-language guide to NCT00312104: phase 3 randomized trial of Insulin Glargine and Insulin Aspart, 325 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00312104
- Phase
- phase 3
- Status
- completed
- Start
- 2002-04
- Completion (planned or actual)
- 2003-03
- Participants
- 325 (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 Glargine and Insulin Aspart.
The trial is conducted in Europe and Africa.
The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart.
The trial involves patients with Type 1 Diabetes.
The registry classes the interventions as drug.
Who Took Part
The registry lists 325 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: Type 1 diabetes for at least 12 months. BMI lesser than or equal to 35 kg/m2. In Austria, age more than 19 years.
The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: proliferate retinopathy or maculopathy; recurrent major hypoglycaemia; any condition or disease such as uncontrolled hypertension or aids/hiv that rule out trial participation according to the judgement of the investigator.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
Being open-label, the Insulin Glargine study did not mask who received what.
It started in 2002-04 with completion listed for 2003-03.
It ran at 46 sites in Germany (37), Austria (5) and South Africa (4).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: HbA1c (time frame: after 26 weeks of treatment).
It also tracked 4 secondary outcomes, for example Adverse events, Body weight, Blood glucose and Hypoglycaemia.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 325 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 and the Insulin Aspart compound page, all human trials.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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.