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A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus
Plain-language guide to NCT00399724: phase 4 randomized trial of Insulin Glargine, 7376 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00399724
- Phase
- phase 4
- Status
- completed
- Start
- 2002-03
- Completion (planned or actual)
- 2003-08
- Participants
- 7376
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- 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.
Primary objective: * To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 7376 planned participants were the target.
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: Subjects with Type 2 Diabetes Mellitus,. Subjects on antidiabetic treatment (oral and/or insulin therapy) for \> 6 months,. Subjects who require a basal long-acting insulin for the control of hyperglycaemia,. BMI \< 40 kg/m².
The full record lists 5 inclusion and 0 exclusion criteria.
How the Study Was Run
The set-up was 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.
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 2002-03 with completion listed for 2003-08.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Incidence of severe hypoglycaemia.
It also tracked 15 secondary outcomes, for example Incidence of any hypoglycaemia, Incidence of symptomatic hypoglycaemia, Incidence of nocturnal hypoglycaemia, Incidence of asymptomatic hypoglycaemia, Adjusted mean change in Hb1Ac (%) and Adjusted mean change in fasting blood glucose (FBG) (mg/dl).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 7376 people.
With 7376 participants it is a large trial for this field.
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.