← Human Trials & Peer-Reviewed Studies
A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus
Plain-language guide to NCT02773368: phase 3 randomized trial of Insulin Glargine and Liraglutide, 420 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02773368
- Phase
- phase 3
- Status
- completed
- Start
- 2016-05-23
- Completion (planned or actual)
- 2017-09-26
- Participants
- 420 (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
In this phase 3 trial, researchers set out to test Insulin Glargine and Liraglutide.
This trial is conducted globally.
The aim of this trial is comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2 diabetes mellitus.
It had two arms (groups): IDegLira (experimental) and IGlar (active comparator).
The registry classes the interventions as drug.
Who Took Part
420 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.
The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.
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 2016-05-23 with completion listed for 2017-09-26.
It ran at 88 sites in United States (24), India (10), Switzerland (8), Russia (7), Spain (7) and Canada (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 32 secondary outcomes, for example Change in Body Weight, Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes, Change in Fasting Plasma Glucose (FPG), Number of Treatment-emergent Adverse Events, Change From Baseline After 26 Weeks in Waist Circumference and Change From Baseline in Fasting Lipid Profile: Cholesterol.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and Liraglutide in 420 people.
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.