Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

It had two arms (groups): Teneli (Teneligliptin) /Teneli + insulin (experimental) and Placebo/Teneli (Teneligliptin) + insulin (placebo comparator).

Teneligliptin for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.

Placebo for 16 weeks (double-blind period) followed by teneligliptin for an additional 36 weeks (open-label period) in combination with insulin.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 148 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 6 exclusion criteria; among the exclusions: patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (cushing disease, acromegaly, etc); patients who are accepting treatments of arrhythmias; patients with serious diabetic complications.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

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

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

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in HbA1c (time frame: at Week 0 and Week 16).

It also tracked 3 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose, Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose and Change From Baseline in 2-hour Postprandial Plasma Glucose.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 148 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.