Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes

What Was Tested

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

This trial is conducted in Europe.

It had two arms (groups): Insulin degludec (experimental) and Insulin glargine (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 actual participants took part.

It was open to men only aged from 18 years up to 69 years.

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

Examples of who could join: Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results. Specific inclusion criteria for subject with type 1 diabetes:. Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening. Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive). Specific inclusion criteria for subject with type 2 diabetes:.

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: subject with a history of or presence of cancer; specific exclusion criteria for subject with type 2 diabetes:; therapy with oral antidiabetic drugs within the past 3 months prior to screening.

How the Study Was Run

Design: randomized, crossover and double-blind.

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 and investigator.

It started in 2006-08 with completion listed for 2006-11.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the glucose infusion rate curve.

It also tracked 1 secondary outcome, for example Area under the insulin degludec/insulin glargine curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 40 people.

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, all human trials.