NCT02292290

Trial for People With Established Type 2 Diabetes During Ramadan

A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Liraglutide vs. a Sulphonylurea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Dual therapy with metformin and Liraglutide is more effective at helping people with established Type 2 Diabetes Mellitus (T2DM) observing Ramadan achieve a triple composite endpoint of weight reduction and/or maintenance and improved HaemaglobinA1c (HbA1c) and no severe hypoglycaemic events.

Detailed description

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. Tradition includes amongst early morning prayers/celebration through feasting. Therefore, participants will be invited to attend the first follow-up after this event (between weeks 2 - 4) and then at 12 weeks post Ramadan. Randomisation will not be revealed until after the baseline data have been collected.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Liraglutide	4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response
DRUG	Liraglutide	4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response.
DRUG	Sulfonylurea or Pioglitazone	Addition to Metformin
DRUG	Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide	As per clinical guidelines for prescription

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2014-11-17
• Last updated: 2020-01-30

Locations

2 sites across 1 country: United Kingdom