A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and Insulin Lispro.

This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).

It had two arms (groups): Glargine (active comparator) and ILPS (experimental).

Glargine plus Insulin Lispro (2-3 injections).

Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections).

The registry classes the interventions as drug.

Who Took Part

The registry lists 374 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: Diabetes Mellitus, Type 2. Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening). Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m\^2. Capable and willing to follow the protocol. Give written consent.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: are taking any glucose-lowering agents (other than those listed in the inclusion criteria above); have a history of severe hypoglycemia in the past 6 months; are pregnant or may become pregnant.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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 2008-04 with completion listed for 2010-02.

It ran at 50 sites in Germany (8), Poland (8), Italy (7), Czechia (6), Romania (4) and Slovakia (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24 (time frame: Baseline, Week 24).

It also tracked 10 secondary outcomes, for example Change From Baseline in HbA1c at Week 12 and Week 24, 7-point Self-monitored Blood Glucose Profiles (SMBG) at Endpoint, Glycemic Variability at Endpoint, Rate Of All Self-reported Hypoglycemic Episodes, Percentage of Participants With Self-Reported Hypoglycemic Episodes and Number of Participants With Adverse Events (AE).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 374 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.