Insulin Glargine During and After the Period of Fasting in Ramadan

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

Primary Objectives : * To compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) in patients with type 2 diabetes treated with insulin glargine (Lantus®) and glimepiride (Amaryl®), before, during and after the period of fasting in Ramadan.

Secondary Objectives : * To assess glycaemic control before, during and after Ramadan in terms of HbA1c, FBG, and 8-point blood glucose profile (FBG and 8-point blood glucose profile will be collected with a blood glucose monitor through a monthly patient diary). * To assess the relationship between hypoglycaemia events during Ramadan and blood glucose control prior and during Ramadan. * To assess patient satisfaction * To document adverse events (all serious adverse events, non serious adverse events) throughout the study (all events will be collected through the monthly patient diary).

The registry classes the interventions as drug.

Who Took Part

450 planned participants were the target.

It was open to people of any sex aged from 35 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 2 Diabetes mellitus (but without history of ketoacidosis);. BMI \> 25 and \< 40 kg/m2;. Willingness to participate and to fast during Ramadan;. Patients should be either:. Insulin naïve patients.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: pregnancy (as determined by pregnancy blood test at inclusion visit); breast- feeding; women of childbearing potential who do not have adequate contraceptive protection.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2005-05 with completion listed for 2006-02.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) before, during and after Ramadan. Glycemic control before, during and after Ramadan in terms of HbA1c, FBG, 8-point blood glucose profile. All other adverse events before, during and after Ramadan.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Glargine in 450 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.