Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs

What Was Tested

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

It had two arms (groups): Intensive insulin regimen (experimental) and insulin regimen (experimental).

The registry classes the interventions as drug.

More on the Plan

The study is divided in 3 periods: 1. a 2-week run-in period, 2. a 12-week treatment period 1 3. a 12-week treatment period 2 study treatment duration per patient: 24 weeks study duration per patient: 26 weeks.

Who Took Part

The registry lists 207 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: In the run-in period:. Male or female patients from 18-75 years old inclusive. Body Mass Index (BMI) between 25 and 40 kg/m2. Signed Informed consent obtained prior to any study procedures. In the treatment period:.

The full record lists 11 inclusion and 17 exclusion criteria; among the exclusions: type 1 diabetes mellitus; clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult; history of impaired hepatic function defined as alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) greater than three times the upper limit of normal.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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

It started in 2010-12 with completion listed for 2012-07.

It ran at 10 sites in Algeria (1), Brazil (1), Israel (1), Lebanon (1), Mexico (1) and Morocco (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c level for patients with addition of glulisine at week 12 (time frame: between week 12 and week 24 (end of treatment period)).

It also tracked 8 secondary outcomes, for example Fasting Plasma Glucose, 7-point Self Monitoring of Blood Glucose, Systolic / diastolic blood pressure, heart rate, weight change and Hypoglycemia (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Glargine in 207 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.