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Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment
Plain-language guide to NCT01620489: phase 3 randomized trial of Liraglutide, 279 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01620489
- Phase
- phase 3
- Status
- completed
- Start
- 2012-06-14
- Completion (planned or actual)
- 2013-08-20
- Participants
- 279 (actual)
- Design
- randomized, double-blind, 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 Liraglutide.
This trial is conducted in Europe and the United States of America (USA).
The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin regimen.
It had two arms (groups): one (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
279 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Body Mass Index (BMI) 20-45 kg/m\^2 (both inclusive).
The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator; impaired liver function, defined as alat (alanine aminotransferase) above or equal to 2.5 times upper normal limit; history of chronic pancreatitis or idiopathic acute pancreatitis.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.
The Liraglutide group and the comparison group ran side by side rather than switching.
As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2012-06-14 with completion listed for 2013-08-20.
It ran at 97 sites in United States (53), Russia (17), United Kingdom (9), Poland (8), France (5) and Ukraine (5).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin) (time frame: Week 0, Week 26).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Liraglutide in 279 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Liraglutide compound page, all human trials.
Our Notes on the Compound
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.