A Phase 4 interventional study of Liraglutide and Liraglutide in Type 2 Diabetes, sponsored by University of Leicester. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-30.
Sponsored by University of Leicester · Phase 4, Interventional, and Treatment
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.
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 99 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Leicester is the lead sponsor of 170 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
addition of Sulfonylurea or Pioglitazone to Metformin
Drug: Sulfonylurea or Pioglitazone
Swap Liraglutide for sulfonylurea or pioglitazone taken as second line therapy (Metformin) first line)
Drug: Liraglutide
Maintain sulfonylurea or pioglitazone as second line therapy (Metformin first line)
Drug: Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide
Addition of Liraglutide to Metformin
Drug: Liraglutide
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response
Also known as: Victoza
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response.
Also known as: Victoza
Addition to Metformin
As per clinical guidelines for prescription
Composite
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: 12 weeks following post Ramadan cinical assessment
HbA1c only
Mean change HbA1c level
Time frame: same as primary, 12 weeks following post Ramadan cinical assessment
The record gives a start of Apr 2011, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liraglutide