Insulin Schemes for Type 2 Diabetes Control

What Was Tested

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

The aim of the study is to determine differences in glycemic control between a basal-bolus scheme insulin and NPH scheme insulin in a population of hospitalized patients with type 2 diabetes in a Noncritical Care Facility in Mexico.

Patients with a recent diagnosis of type 2 and patients on treatment with oral hypoglycaemic agents and insulin or only insulin were included.

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

The registry classes the interventions as drug.

More on the Plan

This is considered a good scheme for handling hyperglycemia, and its possible to have less hypoglycemia episodes, which are possible if an ultra-rapid-acting insulin is added and adequate intake is not performed due to multiple factors related to hospitalization.

Currently, both Glargine and NPH based regimen is practiced in inpatient hospital facilities.

Current practice of inpatient insulin regimen is based on the physicians familiarity with a particular insulin type and personal preference rather than evidenced based knowledge.

There are reports in the literature about the incidence of hypoglycemia with this scheme.

Who Took Part

Enrollment: 75 actual participants took part.

It was open to people of any sex aged from 18 years up to 100 years.

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

Examples of who could join: Patients between 18 and 100 years old. Non-critical patients hospitalized in the service of Internal Medicine (MI), General Surgery (CG) and Traumatology (TyO). Patients receiving a diabetic diet orally.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: parenteral nutrition; hyperglycemia without a known history of diabetes; impaired renal function (glomerular filtration rate less than 30).

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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 2017-11-02 with completion listed for 2018-07-01.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Differences in the Mean Daily Blood Glucose Between a Basal-bolus Scheme and NPH Schemes of Insulin.

It also tracked 2 secondary outcomes, for example the Number of Participants With Mild and Severe Hypoglycemic Events and Number of Participants With Sustained Glycemic Control During Hospital Stay.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 75 people.

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 Insulin Lispro compound page, all human trials.