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Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
Plain-language guide to NCT02622113: phase 4 interventional trial of Insulin (regular human), 139 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02622113
- Phase
- phase 4
- Status
- completed
- Start
- 2014-12
- Completion (planned or actual)
- 2016-04
- Participants
- 139 (actual)
- Design
- na, 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
In this phase 4 trial, researchers set out to test Insulin (regular human).
The extension study was an extension to double-blind study of 16 weeks (TA-7284-11).
It had 1 arm (groups): Canagliflozin (TA-7284) ＋insulin (experimental).
The registry classes the interventions as drug.
Who Took Part
139 actual participants took part.
It was open to people of any sex aged from 20 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients should complete the week 16 assessments in the double-blind study (TA-7284-11).
The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: patients with hereditary glucose-galactose malabsorption or primary renal glucosuria; patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy); patients with serious renal or hepatic disease.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Insulin (regular human) 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 2014-12 with completion listed for 2016-04.
It ran at 7 sites in Japan (7).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) (time frame: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks).
It also tracked 3 secondary outcomes, for example Change in Percentage of HbA1c, Change in Fasting Plasma Glucose and Percentage Change in Body Weight.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Insulin (regular human) in 139 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Insulin (regular human) compound page, all human trials.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
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.