A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes

What Was Tested

The trial (phase 1) is built around Insulin Lispro.

It had two arms (groups): Test (T) (experimental) and Reference (R) (active comparator).

The registry classes the interventions as drug.

Who Took Part

90 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male or female patients, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year. Stable insulin regimen for at least 2 months prior to study (day of insulin regimen switch, with respect to safety of the patient and scientific integrity of the study). Patients with anti-insulin antibody titer at screening ≤ 30.0 kU/L. Body weight between 50.0 kg and 100.0 kg, inclusive, il male , and between 40.0 and 90.0 kg, inclusive, if female, Body Mass Index between 18 and 30.0 kg/m², inclusive.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, more than twice a month); presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician; likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.

How the Study Was Run

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

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

Each person switched between Insulin Lispro 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 Lispro.

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

It started in 2019-03-26 with completion listed for 2019-08-19.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Assessment of PK parameter :INS-AUClast - (time frame: 10 hours).

It also tracked 8 secondary outcomes, for example Assessment of PK parameter:INS-AUC, Assessment of PK parameter:INS-tmax, Assessment of PK parameter:INS-t1/2z, Assessment of PD parameter:GIR-max, Assessment of PD parameter:GIR-tmax and Duration of blood glucose control.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 90 people.

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

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