TAK-329 Glucose Clamp Study

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human).

It had four arms (groups): one (experimental), one (experimental), one (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Type 1 diabetes mellitus (T1DM), also known as insulin-dependent diabetes mellitus or juvenile-onset diabetes, occurs primarily due to β-cell destruction, usually leading to absolute insulin deficiency.

The condition is immune-mediated and is usually idiopathic.

This study will take place at 1 site in the United States.

A total of 36 male and female adult participants with T1DM will take part in the study.

Who Took Part

Enrollment: 37 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: In the opinion of the investigator, the participant or legal guardian is capable of understanding and complying with protocol requirements. Weighs at least 50 kg and has a body mass index between 18.0 and 32.0 kg/m2, inclusive at Screening. Was treated with insulin either in the form of multiple daily injections or as continuous subcutaneous insulin infusion (CSII or "insulin pump") for at least 3 months prior to Screening.

The full record lists 11 inclusion and 27 exclusion criteria; among the exclusions: the participant is participating in another investigational study or has taken any investigational drug within 30 days prior to day -1; has a known hypersensitivity to tak-329, any of its excipients, any compound related to tak-329, or known hypersensitivity to sulfonamides; has a history indicative of proliferative retinopathy or maculopathy and/or severe neuropathy including gastroparesis.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

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

It started in 2011-03 with completion listed for 2011-12.

It ran at 1 site in United States.

What Was Measured

It also tracked 4 secondary outcomes, for example Area under the effect versus time curves (AUEC) of Cortisol During Hypoglycemic Clamp, Incidence of Treatment-Emergent Adverse Events and Incidence of Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 37 people.

Its size is small, so on its own it can only give an early look.

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.