Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients

What Was Tested

This registered phase 4 trial tested Insulin Detemir.

It had 1 arm (groups): Basal-bolus specific insulin regimen (experimental).

Basal-bolus detemir-aspart insulin regimen in hemodialyzed diabetic patients.

The registry classes the interventions as drug.

More on the Plan

All patients who were admitted to the nephrology departments and matched the inclusion criteria between January 1st, 2010, and June 30th, 2012, were consecutively included in the study.

CGM was used to analyze blood glucose excursions at baseline and 1 and 3 months of treatment.

It was started during the first dialysis session and then continued for the next two days at home under ambulatory conditions.

The CGM was continued during the next dialysis session.

Who Took Part

Enrollment: 38 actual participants took part.

It was open to people of any sex aged from 18 years up to 83 years.

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

Examples of who could join: Age between 18 and 83 years. Treatment with insulin injections or oral hypoglycemic agents. On hemodialysis for more than three months.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: unstable anemia or blood transfusions within the two months prior to the beginning of the study; a life expectancy of less than 1 year; chronic inflammatory disease.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Insulin Detemir study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-01 with completion listed for 2012-09.

It ran at 5 sites in France (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean plasma glucose level measured 3 times just before the first hemodialysis session (time frame: Baseline and at 3 months of treatment).

It also tracked 6 secondary outcomes, for example HbA1c, Body weight, Insulin requirements, Symptomatic hypoglycemia and Continuous glucose monitoring parameters.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Detemir in 38 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 Detemir compound page, all human trials.