Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Glargine and Insulin Aspart.

The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) 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

Enrollment: 135 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 aged ≥18 years. Type 1 Diabetes Mellitus (T1DM) treated with insulin for ≥12 months. Body mass index (BMI) 18.0 to 40.0 kilograms per square meter (kg/m\^2). Fasting C-peptide \<0.6 nanograms per milliliter (ng/mL). Willingness to use twice daily (BID) insulin glargine as basal insulin for the duration of the study.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: known or suspected allergy to any component of any of the study drugs; use of pramlintide within 30 days of screening; recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the investigator.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

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.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

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 19 sites in United States (19).

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, 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 Postprandial Glucose (PPG) Excursions.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine and Insulin Aspart in 135 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.