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A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes
Plain-language guide to NCT01794143: phase 3 randomized trial of Insulin Glargine and Liraglutide, 7850 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01794143
- Phase
- phase 3
- Status
- completed
- Start
- 2013-05
- Completion (planned or actual)
- 2021-04-30
- Participants
- 7850 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes; Comparative Effectiveness of Glycemia-lowering Medications
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Insulin Glargine and Liraglutide.
It had four arms (groups): Sulfonylurea (glimepiride) (active comparator), DPP-4 inhibitor (active comparator), GLP-1 receptor agonist (active comparator) and Insulin (glargine) (active comparator).
Sulfonylurea.
DPP-4 inhibitor (sitagliptin).
GLP-1 receptor agonist (liraglutide).
The registry classes the interventions as drug.
Who Took Part
The registry lists 7850 actual participants took part.
It was open to people of any sex aged from 30 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Fluent in either English or Spanish. A negative pregnancy test for all females of childbearing potential (i.e. pre-menopausal, and not surgically sterile).
The full record lists 8 inclusion and 28 exclusion criteria; among the exclusions: more than 10 years of treatment with metformin at time of randomization screening; current need for any specific glucose-lowering medications solely for other conditions, for example for polycystic ovary syndrome; symptomatic hyperglycemia requiring immediate therapy during screening or run-in, in the judgment of the physician.
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.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2013-05 with completion listed for 2021-04-30.
It ran at 36 sites in United States (36).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and Liraglutide in 7850 people.
With 7850 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.