← Human Trials & Peer-Reviewed Studies
A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
Plain-language guide to NCT02688933: phase 4 randomized trial of Insulin Glargine, 638 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02688933
- Phase
- phase 4
- Status
- completed
- Start
- 2016-05-05
- Completion (planned or actual)
- 2017-06-19
- Participants
- 638 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 1 Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Glargine.
It had two arms (groups): HOE901-U300 (experimental) and Lantus (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 638 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Adult participants (male and female) with type 1 diabetes mellitus (T1DM). Signed written informed consent.
The full record lists 2 inclusion and 16 exclusion criteria; among the exclusions: age \<18 years or \>70 years; participants who experienced \>1 episode of severe hypoglycemia resulting in coma/seizures during the last 12 months before screening; participants received less than 1 year treatment with basal plus mealtime insulin.
How the Study Was Run
Design: 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.
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 2016-05-05 with completion listed for 2017-06-19.
It ran at 100 sites in United States (99) and Puerto Rico (1).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Percentage of Time of Mean Glucose Concentration Within the Target Range of [amount hidden]/dL as Obtained From CGM.
It also tracked 5 secondary outcomes, for example Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia, Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year and Coefficient of Variation (CV%) in Mean CGM Glucose.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 638 people.
With 638 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, 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.