Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus

What Was Tested

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

It had 1 arm (groups): APIDRA + LANTUS basal (experimental).

The 2 first weeks, patients will receive subcutaneous injection of Insulin Glulisine and Insulin Glargine once daily in hospital. The rest of the treatement is to be take at home until week 12.

The registry classes the interventions as drug.

Who Took Part

The registry lists 68 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: Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen. BMI \<35 kg/m². Provision of signed and dated informed consent prior to any study procedures. Ability and willingness to complete study diaries and questionnaires. A negative pregnancy test for all females of childbearing potential.

The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: hypersensitivity to insulin glulisine, insulin glargine or one of their excipients; pregnant women; active proliferative diabetic retinopathy.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-07 with completion listed for 2010-07.

It ran at 1 site in Belarus.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean change in Glycosylated haemoglobin (HbA1c) (time frame: Week 12).

It also tracked 5 secondary outcomes, for example Mean Glycosylated haemoglobin (HbA1c), Mean Fasting Blood Glucose and mean Post Prandial Glycemia, Number of documented symptomatic hypoglycaemic episodes and Mean change of Fasting Blood Glucose and Post Prandial Glycemia.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Glargine in 68 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.