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Combinatorial Therapy for Peristent Type 2 Diabetes After Gastric Banding
Plain-language guide to NCT01597531: phase 4 randomized trial of Liraglutide, 1 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01597531
- Phase
- phase 4
- Status
- terminated early
- Start
- 2012-06
- Completion (planned or actual)
- 2014-06
- Participants
- 1 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes; Gastric Banding
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Liraglutide.
It had three arms (groups): Liraglutide only (active comparator), Orlistat only (active comparator) and Liraglutide + Orlistat (active comparator).
The registry classes the interventions as drug.
Who Took Part
1 actual participants took part.
It was open to people of any sex aged from 25 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female,. Age 25-70 years,. Type 2 diabetic,. Weight stable for 3 months,. Status post laparoscopic adjustable gastric banding (LAGB) for at least 1 year,.
The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: prior history of pancreatitis,; prior history of gastroparesis,; glomerular filtration rate (gfr) \< 50,.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.
The Liraglutide group and the comparison group ran side by side rather than switching.
Being open-label, the Liraglutide study did not mask who received what.
It started in 2012-06 with completion listed for 2014-06.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Type 2 diabetes remission (time frame: baseline, 1 and 4 months post-randomization).
It also tracked 3 secondary outcomes, for example Whole body insulin sensitivity, GLP-1 response and First Phase Insulin secretion.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Liraglutide in 1 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
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.