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Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy
Plain-language guide to NCT00598793: phase 3 randomized trial of Insulin Glargine and Insulin Aspart, 242 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00598793
- Phase
- phase 3
- Status
- completed
- Start
- 2002-11
- Completion (planned or actual)
- 2004-03
- Participants
- 242 (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
The trial (phase 3) is built around Insulin Glargine and Insulin Aspart.
This trial is conducted in the United States of America (USA).
The registry classes the interventions as drug.
Who Took Part
The registry lists 242 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Insulin naive Type 2 diabetes. Currently treated with OADs alone or combined with other treatment for at least 3 months. BMI below 40 kg/m2 and body weight below 125 kg.
The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: inability to tolerate metformin or contradictions to its use; pregnant, breastfeeding or intention of becoming pregnant; allergy to any of the trial products.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2002-11 with completion listed for 2004-03.
It ran at 27 sites in United States (27).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): HbA1c (time frame: after 28 weeks of treatment).
It also tracked 5 secondary outcomes, for example Postprandial glucose by 8-point SMBG, Number of hypoglycemic episodes and adverse events and Weight change.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 242 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.