Study of TAK-559 in Treating Subjects With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Insulin (regular human).

It had two arms (groups): one (experimental) and Insulin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Insulin is a primary regulator of blood glucose concentrations.

Insulin also plays an important role in the metabolism of fat and proteins and exerts its influence at the peroxisome proliferator-activated receptor level.

Peroxisome proliferator-activated receptor -alpha receptors are expressed predominantly in skeletal muscle, adipose tissue, heart, liver, kidney, gut, macrophages, and vascular tissue, and play a key role in energy storage, glucose homeostasis, and vascular biology.

Thus, as insulin activates peroxisome proliferator-activated receptor-alpha receptors, this results in the cellular uptake of glucose.

Who Took Part

Enrollment: 348 actual participants took part.

It was open to people of any sex aged from 25 years up to 65 years.

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

Examples of who could join: Had type 2 diabetes mellitus using American Diabetes Association diagnostic criteria, currently treated with insulin therapy. Had a Screening thyroid stimulating hormone level less than or equal to 5.5 μU/mL (5.5 μU/L) and greater than or equal to 0.35 μU/mL (0.35 μU/L). Was willing to continue dietary counseling during study and had dietary advice greater than or equal to 2.5 months prior to Screening. Had a Screening blood pressure less than or equal to 140/95 mm Hg. Was willing to perform daily self-monitoring blood glucose tests.

The full record lists 14 inclusion and 37 exclusion criteria; among the exclusions: had a hypersensitivity to peroxisome proliferator-activated receptor -alpha or gamma agonists, thiazolidinediones, or fibrates; was diagnosed with type 1 diabetes mellitus or hemochromatosis, or had a history of ketoacidosis; required greater than 2 hypertension medications to achieve adequate blood pressure control.

How the Study Was Run

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

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 2003-11 with completion listed for 2004-12.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Incidence of Adverse events (time frame: All visits or at occurrence). Clinical safety lab tests (time frame: Weeks 12, 24, and Final Visit). 12-lead electrocardiogram (time frame: Weeks: 24 and Final Visit).

It also tracked 9 secondary outcomes, for example Change from Baseline in triglycerides, Change from Baseline in cholesterol, Change from Baseline in total, high-density lipoproteins, Change from Baseline in low-density lipoproteins, Change from Baseline in low-density lipoprotein fractionation and Change from Baseline in very low-density lipoprotein.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 348 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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