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Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.
Plain-language guide to NCT00184626: phase 4 randomized trial of Insulin Glargine and Insulin Aspart, 97 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00184626
- Phase
- phase 4
- Status
- completed
- Start
- 2004-09-10
- Completion (planned or actual)
- 2005-10-24
- Participants
- 97 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Insulin Glargine and Insulin Aspart.
This trial is conducted in Asia.
The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin in subjects with Type 2 Diabetes.
The registry classes the interventions as drug.
Who Took Part
The registry lists 97 actual participants took part.
It was open to people of any sex aged from 35 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes. Body mass index equal to or lesser than 35.0 kg/m2. Currently treated with oral hypoglycaemic drug.
The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the investigator.
How the Study Was Run
Design: 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 2004-09-10 with completion listed for 2005-10-24.
It ran at 1 site in Turkey (Türkiye).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: HbA1c (time frame: Measured at end of treatment (26 weeks)).
It also tracked 3 secondary outcomes, for example safety variables, other glycemic variables and Fasting plasma glucose value.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 97 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.
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.