Glargine Versus NPH in Patients With Chronic Kidney Disease

What Was Tested

The trial (phase 4) is built around Insulin Glargine and NPH Insulin (isophane).

Chronic kidney disease (CKD) is one of the most common microvascular complications of diabetes mellitus, and it is the leading cause of end stage renal disease on developed countries.

It had two arms (groups): Glargine insulin (experimental) and NPH insulin (active comparator).

This is an open-label, randomized, two-way crossover study , one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of insulin glargine, regardless of the sequence were grouped as glargine.

This is an open-label, randomized, two-way crossover study , one is IGlar/INPH treatment sequence and, another is INPH/IGlar sequence. Wherein, IGlar refers to glargine insulin and INPH refers to NPH insulin. At the end of the study, all data acquired during the use of NPH insulin, regardless of the sequence were grouped as NPH.

The registry classes the interventions as drug.

More on the Plan

This study consists of a randomized, cross-over, open-label controlled clinical trial.

Patients receiving insulin NPH plus insulin lispro will be oriented to mix both of them in the same syringe at breakfast and lunchtime.

During routine medical appointments the patient should bring the self- monitoring of capillary blood glucose (SMBG), eight points per day once a week, and hypoglycemia score.

A new CGMS will be carried out 24 weeks after therapy has been changed.

Who Took Part

The registry lists 34 actual participants took part.

It was open to people of any sex aged from 40 years up to 80 years.

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

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: patients with systemic neoplasias,; HIV, chronic kidney disease or nephropathy from other etiologies,; severe psychiatric disorders.

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

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

It started in 2013-12 with completion listed for 2016-08.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Difference in A1c Levels (time frame: baseline and 24 weeks). Number of Hypoglycemic Events (time frame: between 1rst and 24 weeks of each treatment arm).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and NPH Insulin (isophane) in 34 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page and the NPH Insulin (isophane) compound page, all human trials.