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A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus
Plain-language guide to NCT01952145: phase 3 randomized trial of Insulin Glargine and Liraglutide, 557 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01952145
- Phase
- phase 3
- Status
- completed
- Start
- 2013-09-20
- Completion (planned or actual)
- 2014-11-04
- Participants
- 557 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Insulin Glargine and Liraglutide.
This trial is conducted globally.
It had two arms (groups): Insulin degludec/liraglutide OD plus metformin (experimental) and Insulin glargine OD plus metformin (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 557 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 0 inclusion and 1 exclusion criteria.
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.
Being open-label, the Insulin Glargine study did not mask who received what.
It started in 2013-09-20 with completion listed for 2014-11-04.
It ran at 91 sites in United States (31), Russia (12), Slovakia (11), Greece (7), Australia (6) and Spain (6).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 26).
It also tracked 2 secondary outcomes, for example Change From Baseline in Body Weight and Number of Treatment Emergent Confirmed Hypoglycaemic Episodes.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and Liraglutide in 557 people.
With 557 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 and the Liraglutide compound page, all human trials.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.
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.