baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus

What Was Tested

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

It had 1 arm (groups): Insulin glargine + insulin glulisine (experimental).

The registry classes the interventions as drug.

More on the Plan

After a two-week run-in period patients will enter a six-month treatment period.

Estimated study duration per patient : 26 weeks (including a 2-week run-in period).

Who Took Part

Enrollment: 206 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Known Type 1 diabetic patients (male or female) treated with any type of insulin regimen, except:. Continuous subcutaneous insulin infusion (CSII, or pump), and. Patients already treated with insulin glargine. Age: 18-60 years inclusive. At least 1 year of continuous insulin treatment.

The full record lists 15 inclusion and 10 exclusion criteria; among the exclusions: history of hypersensitivity to insulin glargine and/or insulin glulisine; pregnant, breast-feeding or women of childbearing potential not using efficient contraception; brittle diabetes.

How the Study Was Run

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

Being open-label, the Insulin Glargine study did not mask who received what.

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

It started in 2010-11 with completion listed for 2013-01.

It ran at 43 sites in South Africa (12), Brazil (6), Argentina (5), Colombia (5), Tunisia (5) and Algeria (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)) (time frame: between baseline (week 0) and endpoint (week 24)).

It also tracked 7 secondary outcomes, for example Change of HbA1c, Fasting Blood Glucose (FBG), 7-point Self Monitoring of Blood Glucose (SMBG) and Symptomatic hypoglycemias.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Glargine in 206 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.