TOFO Insulin Combination Trial

What Was Tested

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

To assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks.

Secondary Objectives: To assess the effects of tofogliflozin in comparison to placebo on: * Body weight * Fasting plasma glucose (FPG) * Postprandial plasma glucose (PPG) To assess the long term safety and tolerability of tofogliflozin.

It had two arms (groups): tofogliflozin (experimental) and placebo (placebo comparator).

Tofogliflozin administered once daily for 52 weeks. Insulin administered as base treatment.

Placebo administered once daily for 16 weeks. After 16-weeks, Tofogliflozin administered once daily for 36 weeks. Insulin administered as base treatment.

The registry classes the interventions as drug.

More on the Plan

The total study duration from screening for a patient can be approximately up to 1 year, including a screening period of 2 weeks, double-blinded placebo controlled treatment period of 16 weeks, an open-labeled extension period of 36 weeks, and a follow-up period of 3 days.

Who Took Part

211 actual participants took part.

It was open to people of any sex aged from 20 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients aged 20-75 years old with type 2 diabetes mellitus (T2DM). Basal bolus (BB), Bolus, Premix, Basal supported oral therapy (BOT) regimens used for more than 12 weeks before screening. Only Dipeptidyl peptidase-4 inhibitor is allowed for basal supported oral therapy (BOT) regimen. Body mass index (BMI) ≥18.5 kg/m\^2 and \<35.0 kg/m\^2. No change of antihypertensive, anti-hypercholesterolemia and uric acid lowering drug 4 weeks before screening.

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: type 1 diabetes mellitus; pregnancy or lactation; severely uncontrolled glycemic situation.

How the Study Was Run

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

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 and investigator.

It started in 2014-06 with completion listed for 2016-01.

It ran at 30 sites in Japan (30).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c from baseline (time frame: 16 weeks after first intake of investigational product).

It also tracked 4 secondary outcomes, for example Change of Body Weight (BW) from baseline, Change of FPG from baseline, Change of PPG from baseline and Number of subjects with adverse events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 211 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.