Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 2 trial tested Insulin Glargine and Insulin Aspart.

The purpose of the study was to compare Humalog (insulin lispro)-recombinant human hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.

It had two arms (groups): Lispro-PH20/Insulin lispro (experimental) and Aspart-PH20/Insulin Lispro (experimental).

The registry classes the interventions as drug.

More on the Plan

Participants that did not meet 1 or more of these criteria during a 4- to 6-week Titration Period were not randomized.

Who Took Part

The registry lists 132 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: Males or females ≥18 years. Type 2 diabetes mellitus (T2DM) treated with insulin ≥12 months and prandial insulin (at least 2 meals per day) for ≥2 months. Body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m\^2). Fasting C-peptide \<0.6 nanograms per milliliter (ng/mL). Willingness to use insulin glargine twice a day as basal insulin for the duration of the study.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: known or suspected allergy to any component of any of the study drugs; exclusive use of pre-mixed insulins; use of pramlintide, exenatide, and/or liraglutide within 30 days of screening.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-08 with completion listed for 2011-08.

It ran at 22 sites in United States (22).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period (time frame: Baseline, Week 12 and Week 24).

It also tracked 5 secondary outcomes, for example Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time, Rates of Hypoglycemia at the End of Each Treatment Period, Change From Baseline in Body Weight at the End of Each Treatment Period and Mean Daily PPG Excursions.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine and Insulin Aspart in 132 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 Aspart compound page, all human trials.