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Phase 4 Study to Evaluate Treatment Optimization With Once-daily Insulin Glargine 300 U/mL
Plain-language guide to NCT03406000: phase 4 interventional trial of Insulin Glargine, 170 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03406000
- Phase
- phase 4
- Status
- completed
- Start
- 2018-01-22
- Completion (planned or actual)
- 2019-02-04
- Participants
- 170 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Type I Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Glargine.
It had 1 arm (groups): Insulin glargine (U300) (experimental).
The registry classes the interventions as drug.
More on the Plan
The estimated average study duration is 29 weeks, including run-in period of 4 weeks; treatment period of 24 weeks, and follow-up period of 1 week.
Who Took Part
170 actual participants took part.
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: Male or Female. Age ≥ 18 years. With Type 1 diabetes mellitus. Being treated twice-daily with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year. Patients who have signed an Informed Consent Form.
The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: type 2 diabetes mellitus; known hypoglycemia unawareness; repeated episodes of severe hypoglycemia or diabetes ketoacidosis within the last 12 months.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2018-01-22 with completion listed for 2019-02-04.
It ran at 11 sites in Brazil (11).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Mean change in HbA1c (time frame: From baseline to Week 24).
It also tracked 16 secondary outcomes, for example Mean change in HbA1c, Mean change in fasting plasma glucose (FPG), Mean change in fasting SMBG, Mean change in 8-point SMBG, Proportion of patients with no deterioration in HbA1c and Proportion of patients with no deterioration in HbA1c.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Insulin Glargine in 170 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.