A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine and Insulin Lispro.

The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.

It had two arms (groups): Premixed Insulin (experimental) and Basal-Bolus (active comparator).

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 402 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Present with type 2 diabetes mellitus. Have been receiving twice-daily premixed insulin therapy with or without metformin and/or alpha-glucosidase inhibitors, for at least six months prior to study entry.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: within the last 3 months prior to entry into the study, are taking any non-permitted glucose-lowering agents, or are taking any non-permitted oral antihyperglycaemic medications; are women who are breastfeeding; have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night).

How the Study Was Run

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

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

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 2011-02 with completion listed for 2012-11.

It ran at 14 sites in China (6), South Korea (4) and Taiwan (4).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 9 secondary outcomes, for example Change in HbA1c From Baseline to 12 Week Endpoint, The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks, Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks, Percentage of Participants With Hypoglycemic Episodes (Incidence), The Rate of Hypoglycemic Episodes and Percentage of Participants Experiencing a Severe Hypoglycemic Episode.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 402 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.