Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.

What Was Tested

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

It had three arms (groups): Insulin (placebo comparator), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme.

Dipeptidyl peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion.

Individuals who participate in this study will be required to commit to a screening visit and up to 14 additional visits at the study center.

Study participation is anticipated to be about 34 weeks (or 8.5 months).

Who Took Part

390 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: No treatment with antidiabetic agents other than insulin and metformin within the 8 weeks prior to Randomization. Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2. Systolic blood pressure less than or equal to180 mm Hg and diastolic pressure less than or equal to 110 mm Hg. Alanine aminotransferase less than or equal to 3 times the upper limit of normal. Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject is clinically euthyroid.

The full record lists 17 inclusion and 17 exclusion criteria; among the exclusions: history of laser treatment for proliferative diabetic retinopathy within the 6 months prior to screening; history of treated diabetic gastric paresis; history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to screening.

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.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

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 2006-02 with completion listed for 2007-05.

It ran at 60 sites in United States (45), Argentina (1), Australia (1), Brazil (1), Chile (1) and Czechia (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (time frame: Baseline and Week 26).

It also tracked 32 secondary outcomes, for example Change From Baseline in Glycosylated Hemoglobin (Week 4), Change From Baseline in Glycosylated Hemoglobin (Week 8), Change From Baseline in Glycosylated Hemoglobin (Week 12), Change From Baseline in Glycosylated Hemoglobin (Week 16), Change From Baseline in Glycosylated Hemoglobin (Week 20) and Change From Baseline in Fasting Plasma Glucose (Week 1).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 390 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.