Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test NPH Insulin (isophane).

This trial is conducted in South America.

It had two arms (groups): A (active comparator) and B (experimental).

The registry classes the interventions as drug.

Who Took Part

402 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: Type 2 diabetes for at least 12 months. Current NPH treatment for at least 3 months - alone or as the only insulin in combination with OADs. Body Mass Index (BMI) less than or equal to 40 kg/m2.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: treatment with glucagon-like peptide 1 mimetics or dipeptityl peptidase iv inhibitors; known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the investigator; known or suspected allergy to trial products or related products.

How the Study Was Run

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

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

The NPH Insulin (isophane) group and the comparison group ran side by side rather than switching.

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

It started in 2008-02 with completion listed for 2009-03.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: For the duration of the trial).

It also tracked 8 secondary outcomes, for example Fructosamine, FPG, 4-point SMPG profiles, Incidence of hypoglycaemic episodes, Frequency and severity of adverse events (including injection site reactions) and Laboratory safety parameters (haematology, biochemistry and lipids).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NPH Insulin (isophane) in 402 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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