Trial for People With Established Type 2 Diabetes During Ramadan

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

It had four arms (groups): Monotherapy 2 (active comparator), Dual Therapy 1 (experimental), Dual therapy 2 (active comparator) and Monotherapy (experimental).

Addition of Sulfonylurea or Pioglitazone to Metformin.

Swap Liraglutide for sulfonylurea or pioglitazone taken as second line therapy (Metformin) first line).

Maintain sulfonylurea or pioglitazone as second line therapy (Metformin first line).

The registry classes the interventions as drug.

More on the Plan

Participants in the control arm will essentially continue with their standard routine care and those in the intervention groups will either receive Liraglutide in addition to metformin or those on dual therapy will switch from their sulphonylurea/pioglitazone to Liraglutide and continue with metformin.

Informed consent and baseline data will be collected 4-8 weeks prior to the start of Ramadan.

This will allow time for a run in period for the titration of Liraglutide prior to the fasting period.

Ramadan is followed by Eid-al-Fitr a 3-day Islamic holiday that marks the end of this holy month.

Who Took Part

The registry lists 99 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: Individuals ≥ 18 years old with established T2DM on metformin only. Or dual therapy of metformin plus a sulphonylurea or pioglitazone.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: are pregnant or breast feeding; suffer from terminal illness; are unable to provide informed consent.

How the Study Was Run

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

Because people in this Liraglutide 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.

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

It started in 2011-04 with completion listed for 2012-12.

It ran at 2 sites in United Kingdom (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Composite (time frame: 12 weeks following post Ramadan cinical assessment).

It also tracked 1 secondary outcome, for example HbA1c only.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 99 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.