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Opposing Step-by-step Insulin Reinforcement to Intensified Strategy
Plain-language guide to NCT00174642: phase 3 randomized trial of Insulin Glargine, 811 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00174642
- Phase
- phase 3
- Status
- completed
- Start
- 2004-12
- Completion (planned or actual)
- 2008-12
- Participants
- 811 (actual)
- 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
The trial (phase 3) is built around Insulin Glargine.
It had three arms (groups): 1 (experimental), 2 (experimental) and 3 (experimental).
Insulin Glargine + 3 bolus of Insulin Glulisine + Metformin.
Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin.
Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue.
The registry classes the interventions as drug.
Who Took Part
811 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: Type 2 diabetic. BMI ≤ 40 kg/m².
The full record lists 4 inclusion and 19 exclusion criteria; among the exclusions: type 1 diabetes mellitus; treatment with oads only; treatment with thiazolidinediones.
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.
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 2004-12 with completion listed for 2008-12.
It ran at 18 sites in Belgium (1), France (1), Germany (1), Greece (1), Hungary (1) and Ireland (1).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): HbA1c (time frame: From the beginning to the end of the study). 24-hour blood glucose levels (time frame: From the beginning to the end of the study). symptomatic hypoglycemia (diurnal and nocturnal) (time frame: From the beginning to the end of the study).
It also tracked 2 secondary outcomes, for example Vital signs and Adverse events.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 811 people.
With 811 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.