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Efficacy and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes
Plain-language guide to NCT00619697: phase 4 randomized trial of Insulin Glargine and Insulin Aspart, 260 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00619697
- Phase
- phase 4
- Status
- completed
- Start
- 2003-12
- Completion (planned or actual)
- 2005-03
- Participants
- 260 (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
This registered phase 4 trial tested Insulin Glargine and Insulin Aspart.
This trial is conducted in Europe.
The registry classes the interventions as drug.
Who Took Part
260 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 2 diabetes for at least 6 months. Insulin naive. Short term insulin treatment (7 days or less within the last 6 months) is allowed. Previous treatment with oral antidiabetic drugs for at least 4 months. Judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen. BMI below 40 kg/m2.
The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: the receipt of any other investigational drug within 4 weeks before screening; A history of drug or alcohol abuse within the last 12 months; severe, uncontrolled hypertension.
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 Glargine group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2003-12 with completion listed for 2005-03.
It ran at 54 sites in Germany (31), Austria (8), Poland (5), Hungary (3), Slovenia (3) and Czechia (2).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): HbA1c (time frame: after 26 weeks of treatment).
It also tracked 5 secondary outcomes, for example HbA1c, Plasma glucose profiles, Change in body mass index, Incidence of hypoglycaemic episodes and Safety profile.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 260 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.