Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast

What Was Tested

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

This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.

It had two arms (groups): Glargine (active comparator) and Premixed Insulin Lispro (experimental).

Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs).

Premixed Insulin Lispro (mid-mixture or low-mixture) 1,2 or 3 injections plus OAMs.

The registry classes the interventions as drug.

Who Took Part

344 actual participants took part.

It was open to people of any sex aged from 30 years up to 74 years.

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

Examples of who could join: Diabetes Mellitus, Type 2. Have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione \[TZD\]) without insulin, for at least 90 days prior to Visit 1. Capable and willing to follow the protocol. Give written consent.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: are taking a tzd whose country label does not allow in combination with insulin; are taking any glucose-lowering agents (other than specified in the inclusion criteria above); have a body mass index greater than 40 kg/m\^2.

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.

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

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

It started in 2008-04 with completion listed for 2010-11.

It ran at 27 sites in Spain (5), Egypt (4), India (4), Portugal (4), Romania (4) and Turkey (Türkiye) (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint (time frame: 48 weeks).

It also tracked 10 secondary outcomes, for example Percentage of Participants Using Each Possible Final Insulin Regimen, HbA1c Over Time, 7-point Self-monitored Blood Glucose Profiles, Mean Postprandial Blood Glucose Values, Body Weight Change From Baseline to Endpoint and Incidence of All Self-reported Hypoglycemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 344 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.