A Prospective, Multicenter, Randomized, Open-label Study of 12 Week Duration to Evaluate the Effect of VILDagliptin Added to Insulin on Glycaemic Control in haemoDIALyzed Patients With Type 2 Diabetes: Probe Analysis of CGM

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

Diabetic patients on dialysis have a high burden of morbidity and mortality, particularly from cardiovascular disease.

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

The registry classes the interventions as drug.

Who Took Part

70 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age \> 18 years. TGO, TPO and lipase \< 3x ULN. Blood transfusion in the 2 previous months. Life expectancy less than 1 year. Chronic inflammatory disease.

The full record lists 18 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

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

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2014-06 with completion listed for 2017-10.

It ran at 13 sites in France (13).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM (time frame: up to day 3).

It also tracked 3 secondary outcomes, for example CGM parameters at baseline and month 3, Number of hypoglycaemic events and Mean HbA1C and Glycated albumin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 70 people.

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.