Randomised Open Label Study of Insulin Degludec Versus Insulin Glargine U100 in Ramadan

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

It had two arms (groups): Insulin glargine U100 (active comparator) and insulin degludec U100 (active comparator).

Intervention: half of the subjects will be randomised to insulin glargine U100 basal insulin treatment (or continued on glargine if already treated) that will be administered daily in the evening.

Intervention: half of the subjects will be randomised to insulin degludec U100 basal insulin treatment that will be administered daily in the evening.

The registry classes the interventions as drug.

More on the Plan

During Ramadan fasting blood will be measured before Iftar.

However, should they wish to continue on insulin glargine U100/ then this will be available to be continued per local guidelines.

Just prior to Ramadan: This is likely to be within 1-2 weeks (14 day window) before Ramadan to logistically get all patients in for that blood test.

Visit 6 (two weeks after Ramadan) and will include.

Who Took Part

273 actual participants took part.

It was open to people of any sex aged from 21 years up to 75 years.

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

Examples of who could join: Male subjects with type 2 diabetes between the age of 20-75 years who can speak and understand Arabic or English. Female subjects with type 2 diabetes between the age of 20-75 years who can speak and understand Arabic or English. Patients must be on any basal insulin (once daily). Patients must be on any basal insulin (twice daily). Body Mass Index \<40kg/m2.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: type 1 diabetes; type 2 diabetes on a basal bolus regimen or those on premix insulin or on self-mix insulin; on glp-1 receptor agonists medication.

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2018-01-07 with completion listed for 2018-08-03.

It ran at 1 site in Qatar.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Comparison of the glycemic control of insulin glargine U100 with insulin degludec in patients with type 2 diabetes from baseline to end of Ramadan (time frame: 6 weeks).

It also tracked 4 secondary outcomes, for example Hypoglycemia between arms, HbA1c end point achieved and Incidence of Treatment-Emergent Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 273 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.