Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

It had two arms (groups): Canagliflozin (TA-7284) ＋insulin (experimental) and Placebo＋insulin (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 146 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 who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug. Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (cushing's syndrome, acromegaly, etc.); patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy); patients with hereditary glucose-galactose malabsorption or primary renal glucosuria.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2014-08 with completion listed for 2015-07.

It ran at 7 sites in Japan (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c From Baseline (time frame: baseline and Week 16).

It also tracked 4 secondary outcomes, for example Change in Fasting Plasma Glucose, Percent Change in Body Weight and Change in Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 146 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.