Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients

What Was Tested

The trial (phase 4) is built around Insulin Aspart.

This trial is conducted in Africa and Asia.

The aim of the trial is to compare patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in type 2 diabetes patients uncontrolled on NPH insulin.

It had two arms (groups): Subject-driven titration (experimental) and Investigator-driven titration (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 155 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: Diagnosed with type 2 diabetes for a minimum of 12 months prior to screening. Currently treated with a NPH insulin for at least 3 months prior to screening. Body Mass Index (BMI) below or equal to 40.0 kg/m\^2. Able and willing to eat at least 2 main meals each day during the trial. Able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (SMPG), injection regimen and titrating themselves according to the protocol.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: treatment with any thiazolidinedione (tzd) and glucagon-like peptide-1 (glp-1) receptor agonists or pramlintide within the last 3 months prior to screening; previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations); known proliferative retinopathy or maculopathy requiring treatment.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2012-05-26 with completion listed for 2015-07-09.

It ran at 15 sites in Saudi Arabia (4), Egypt (3), Indonesia (2), Morocco (2), Tunisia (2) and Vietnam (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c From Baseline (time frame: Week 0, week 20).

It also tracked 4 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline, Number of Hypoglycaemic Episodes During the Trial From Baseline, Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D) and Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 155 people.

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

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