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Insulin Glargine in Type 1 Diabetes Mellitus
Plain-language guide to NCT00272090: phase 3 randomized trial of Insulin Glargine, 489 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00272090
- Phase
- phase 3
- Status
- completed
- Start
- 2002-11
- Completion (planned or actual)
- 2005-12
- Participants
- 489 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Insulin Glargine.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 489 actual participants took part.
It was open to people of any sex aged from 18 years up to 60 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Subjects with type 1 diabetes mellitus for more than three years. Subjects on multiple daily injection insulin therapy, basal-bolus scheme therapy. Body Mass Index (BMI) \< 30 kg/m2. Willingness to accept intensive insulin therapy. Ability and willingness to perform SMBG using plasma glucose meter.
The full record lists 8 inclusion and 26 exclusion criteria; among the exclusions: diabetes other than type 1 diabetic mellitus; congestive heart failure nyha class ii; acute or chronic metabolic acidosis, including diabetic ketoacidosis.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.
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 2005-12.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: severe nocturnal hypoglycemias will be measured throughout the study period.
It also tracked 3 secondary outcomes, for example HbA1c will be measured at basal and 8/16 weeks after start of treatment, 8 point glucose profile will be measured during last 2 weeks before each scheduled visit and severe hypoglycemias and nocturnal hypoglycemias will be measured throughout the study period.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 489 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, all human trials.
Our Notes on the Compound
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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.