24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine

What Was Tested

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

The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications.

It had two arms (groups): 1 (active comparator) and 2 (active comparator).

Lispro mixture 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.

Glargine, once-daily, SC injection, given in conjunction with oral antidiabetic medications.

The registry classes the interventions as drug.

Who Took Part

The registry lists 15 actual participants took part.

It was open to people of any sex aged from 21 years up to 80 years.

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

Examples of who could join: Have type 2 diabetes. Single or multiple OAMs for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or. Insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or. A combination of the above. Are greater than or equal to 21 and less than 80 years of age.

The full record lists 12 inclusion and 5 exclusion criteria; among the exclusions: have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study; are currently treated with a meglitinide without sulfonylurea; have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

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

It started in 2003-05 with completion listed for 2004-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Combined morning and evening mean 2 hour postprandial plasma glucose during each 24 hour inpatient period (time frame: At end of treatment arm or 3 months).

It also tracked 8 secondary outcomes, for example HbA1c, 2 hour plasma glucose excursions, plasma glucose AUC, and plasma glucose AUC excursions after the three main test meals combined, The mean amplitude of glycemic excursion and Concentration of plasma triglycerides and free fatty acids.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 15 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the Insulin Lispro compound page, all human trials.