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Effect of Combined Incretin-Based Therapy Plus Canagliflozin on Glycemic Control and the Compensatory Rise in Hepatic Glucose Production in Type 2 Diabetic Patients
Plain-language guide to NCT02324842: not phased randomized trial of Liraglutide, 45 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02324842
- Phase
- not phased
- Status
- completed
- Start
- 2014-11
- Completion (planned or actual)
- 2018-03-28
- Participants
- 45 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Liraglutide.
It had three arms (groups): Canagliflozin (active comparator), liraglutide (active comparator) and canagliflozin plus liraglutide (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 45 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male and female subjects between the ages of 18-70. Subjects with Type 2 Diabetes Mellitus (T2DM). Stable weight (± 3 lbs) over the preceding 3 months.
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: subjects taking drugs known to affect glucose metabolism (other than metformin) will be excluded; unstable body weight (change of greater than ±3 lbs over the preceding 3 months); participates in excessively heavy exercise program.
How the Study Was Run
The set-up was randomized, single-group and open-label.
The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.
Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2014-11 with completion listed for 2018-03-28.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: HbA1c at 4 Months (time frame: Approximately 4 months). Fasting Plasma Glucose (FPG) at 4 Months (time frame: Baseline to Approximately 4 months).
It also tracked 1 secondary outcome, for example Body Mass Index (BMI) at 4 Months.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Liraglutide in 45 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.