Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies

What Was Tested

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

The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal insulin glargine and once-daily prandial insulin lispro, in participants with Type 2 Diabetes.

It had two arms (groups): Insulin lispro low mixture (LM) (experimental) and Insulin glargine+insulin lispro (active comparator).

Two daily injections (breakfast and dinner) of insulin lispro mix 75/25.

Once-daily (bedtime) basal insulin glargine and once-daily (before the main meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 478 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 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 taking metformin and/or pioglitazone. Have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days. Not pregnant or breastfeeding.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: have type 1 diabetes; have a body mass index (bmi) greater than 45 kilograms per square meter (kg/m2); have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study.

How the Study Was Run

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

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

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2011-04 with completion listed for 2012-11.

It ran at 18 sites in South Korea (4), Argentina (2), Brazil (2), China (2), Egypt (2) and India (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population) (time frame: Baseline, 24 weeks). Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population) (time frame: Baseline, 24 weeks).

It also tracked 12 secondary outcomes, for example Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint, Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks, 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks, Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks, Change in Weight From Baseline to 12 Weeks and 24 Weeks and The Number of Participants With a Hypoglycemic Episodes (Incidence).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 478 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.