liraglutide
Drug4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response
Other names: Victoza
NCT Number: NCT02292290
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
University Hospitals of Leicester, Leicester, Leicestershire, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response
Other names: Victoza
Addition to Metformin
As per clinical guidelines for prescription
Time frame: 12 weeks following post Ramadan cinical assessment
A composite endpoint of a reduction in weight, reduction/maintenance of HbA1c and elimination of severe hypoglycaemic (defined as hospital admission) events post intervention.
Time frame: same as primary, 12 weeks following post Ramadan cinical assessment
Mean change HbA1c level
University of Leicester
Other
A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Liraglutide vs. a Sulphonylurea
Acronym: T4R
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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