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Insulin Glargine "All to Target" Trial
Plain-language guide to NCT00384085: phase 4 randomized trial of Insulin Glargine and Insulin Aspart, 588 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00384085
- Phase
- phase 4
- Status
- completed
- Start
- 2006-05
- Completion (planned or actual)
- 2010-03
- Participants
- 588 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Glargine and Insulin Aspart.
It had three arms (groups): Lantus/Apidra-3 (experimental), Lantus/Apidra-1 (experimental) and Novolog Mix 70/30 (experimental).
Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
Premixed insulin (Novolog® Mix 70/30) added to oral agents.
The registry classes the interventions as drug.
Who Took Part
The registry lists 588 actual participants took part.
It was open to people of any sex aged from 30 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female patients. 30 to 80 years of age. Body Mass Index \<45 kg/m2. With Type 2 diabetes mellitus for at least 2 years. On stable dual or triple oral therapy for at least 3 months.
The full record lists 8 inclusion and 0 exclusion criteria.
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 2006-05 with completion listed for 2010-03.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population (time frame: At week 60).
It also tracked 5 secondary outcomes, for example Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30), Adjusted Incidence Rate of Hypoglycemia and Adjusted Hypoglycemic Event Rates (Event/Patient-year).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 588 people.
With 588 participants it is a large trial for this field.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.