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A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
Plain-language guide to NCT02420262: phase 3 randomized trial of Insulin Glargine and Insulin Aspart, 506 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02420262
- Phase
- phase 3
- Status
- completed
- Start
- 2015-07-26
- Completion (planned or actual)
- 2016-10-05
- Participants
- 506 (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 Insulin Aspart.
This trial is conducted globally.
It had two arms (groups): IDegLira (experimental) and IGlar plus IAsp (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 506 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 at least 18 years at the time of signing informed consent. Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening. Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening. Body mass index (BMI) below or equal to 40 kg/m\^2.
The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: impaired liver function, defined as alanine aminotransferase (alt) at least 2.5 times upper limit of normal; screening calcitonin at least 50 ng/l; history of pancreatitis (acute or chronic).
How the Study Was Run
Design: 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.
Being open-label, the Insulin Glargine study did not mask who received what.
It started in 2015-07-26 with completion listed for 2016-10-05.
It ran at 117 sites in United States (50), France (12), Russia (7), Czechia (6), Greece (6) and Israel (6).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, Week 26).
It also tracked 4 secondary outcomes, for example Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes and Change in Body Weight.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 506 people.
With 506 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 Insulin Aspart 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.
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
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.