Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

Insulin Glargine + Insulin Glulisine.

Insulin Glulisine.

The registry classes the interventions as drug.

Who Took Part

The registry lists 15 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: Men and women with type 2 diabetes that will need enteral nutrition with carbohydrate content. Informed consent (patient or legally authorized representative).

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: hypersensibility to insulin glargine or glulisine, or any other component of the insulin formulation; use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months; history of diabetic ketoacidosis or hyperosmolar hyperglycaemic state or ketonuria.

How the Study Was Run

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

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.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2010-02 with completion listed for 2011-02.

It ran at 10 sites in Brazil (10).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glycaemic parameters assessment (time frame: During the period of 7 Days of treatment).

It also tracked 2 secondary outcomes, for example Incidence of moderate and severe hyperglycemia and Incidence of symptomatic, nocturnal and severe hypoglycemias.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 15 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.