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Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment
Plain-language guide to NCT00046462: phase 3 randomized trial of Insulin Glargine, 240 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00046462
- Phase
- phase 3
- Status
- completed
- Start
- 2001-11
- Completion (planned or actual)
- 2004-11
- Participants
- 240
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Insulin Glargine.
The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.
The registry classes the interventions as drug.
Who Took Part
The registry lists 240 planned participants were the target.
It was open to people of any sex aged from 18 years up to 79 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients between 18 - 79 years of age.
The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: major cardiovascular events.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2001-11 with completion listed for 2004-11.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy (time frame: During the Study Conduct).
It also tracked 6 secondary outcomes, for example Occurrence of hypoglycemia, Change in fasting plasma glucose, Time to glycemic control, Change in body weight and Change in serum lipid profile.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 240 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.