ß-Cell Function and Glycemic Control in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

It had three arms (groups): Metformin (active comparator), Sitagliptin (experimental) and Insulin (experimental).

The registry classes the interventions as drug.

More on the Plan

There is a progressive deterioration in ß-cell function and mass in type 2 diabetics.

This study also can assess what readily available parameter would predict which patients will achieve long-term successful glycemic control after correction of glucose toxicity.

Who Took Part

The registry lists 160 planned participants were the target.

It was open to people of any sex aged from 30 years up to 80 years.

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

Examples of who could join: Recently diagnosed type 2 diabetic patients. Those who age between 30 and 80 years old and can inject insulin by themselves.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-09 with completion listed for 2013-12.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The primary outcome was the comparison of A1C change (time frame: Dec. 2013).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 160 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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