Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Liraglutide.

This trial is conducted in Africa and Asia.

It had two arms (groups): Liraglutide+Metformin (experimental) and Sulphonylurea and Metformin (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 343 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: \- Body Mass Index (BMI) equal to or above 20 kg/m\^2. \- Subjects who have expressed their intention to fast (daytime, i.e. between sunrise and sunset) during Ramadan after receiving medical counselling regarding the risk of fasting.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: \- any chronic disorder or severe disease which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol; \- history of chronic pancreatitis or idiopathic acute pancreatitis; \- screening calcitonin value equal to or above 50 ng/l.

How the Study Was Run

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

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

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

It started in 2014-01-09 with completion listed for 2014-09-01.

It ran at 41 sites in India (9), South Africa (8), Malaysia (7), United Arab Emirates (6), Algeria (5) and Israel (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Fructosamine From Start of Ramadan to End of Ramadan (time frame: Day -1, day 29).

It also tracked 9 secondary outcomes, for example Fructosamine at End of Ramadan, Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG), Change From Baseline to End of Ramadan in Fasting Plasma Glucose, Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c), Change From Baseline to End of Ramadan in Body Weight and Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 343 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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