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To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin.
Plain-language guide to NCT05702073: phase 3 randomized trial of Insulin Glargine, 423 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05702073
- Phase
- phase 3
- Status
- completed
- Start
- 2023-03-31
- Completion (planned or actual)
- 2024-06-11
- Participants
- 423 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- 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 two arms (groups): INS068 (experimental) and IGlar (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 423 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.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: known or suspected allergy or intolerance to investigational medicinal products or related products; hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months; potentially unstable diabetic retinopathy or macular degeneration that requires treatment (e.g., laser, surgical, or injectable medications) within the previous 6 months.
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 2023-03-31 with completion listed for 2024-06-11.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in HbA1c (time frame: Week 0 to Week 26).
It also tracked 12 secondary outcomes, for example Change in FPG(fasting plasma glucose), per-breakfast SMPG, 8-point SMPG profiles, Proportion of Subjects requiring rescue therapy during treatment, Frequency and severity of adverse events and Incidence and rate of Hypoglycemic events.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 423 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.