Study of Ipragliflozin in Patients With Type 2 Diabetes Mellitus Receiving Insulin Therapy

What Was Tested

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

It had 1 arm (groups): Ipragliflozin Group (experimental).

Ipragliflozin will be administered orally for 24 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 103 actual participants took part.

It was open to people of any sex aged from 20 years up to 74 years.

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

Examples of who could join: The subject has been receiving insulin therapy for the treatment of diabetes mellitus. The subject has type 2 diabetes mellitus and has been receiving insulin monotherapy or insulin therapy in combination with one or two oral hypoglycemic agents. The subject has a body mass index (BMI) of \>23.0 kg/m2. If the subject is a female, she must satisfy the following criteria. The subject is not of childbearing potential and satisfies any of the following criteria. The subject is post-menopausal (absence of menses for at least 1 year).

The full record lists 14 inclusion and 18 exclusion criteria; among the exclusions: the subject has type 1 diabetes mellitus; the subject has any symptom of dysuria, anuria, oliguria or urinary retention; the subject has proliferative retinopathy.

How the Study Was Run

It was run as a single-group and open-label study.

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 2016-07-29 with completion listed for 2017-11-09.

It ran at 15 sites in Japan (15).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 21 secondary outcomes, for example Change from baseline in HbA1c, Change from baseline in fasting plasma glucose, Change from baseline in cholesterol, Change from baseline in glycoalbumin, Change from baseline in leptin and Change from baseline in adiponectin.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin (regular human) in 103 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.