Type 2 Diabetes
Conditions
Keywords
Diabetes, Liraglutide, Ramadan, fasting
Brief 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.
Interventions
DRUGLiraglutide
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response
DRUGSulfonylurea or Pioglitazone
Addition to Metformin
DRUGMaintain dual therapy (Sulf/Pio) as comparator to Liraglutide
As per clinical guidelines for prescription
Sponsors
University Hospitals, Leicester
University Hospital Birmingham
University of Leicester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Individuals ≥ 18 years old with established T2DM on metformin only * or dual therapy of metformin plus a sulphonylurea or pioglitazone * with a HbA1c between 7 - 11 % if on monotherapy and between 6.5 - 12% if on dual therapy
Exclusion criteria
* Are pregnant or breast feeding * Suffer from terminal illness * Have significant renal or liver impairment * Are unable to provide informed consent * Have severe and enduring mental health problems * Are not primarily responsible for their own care * Are receiving insulin therapy * Type 1 diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c only | same as primary, 12 weeks following post Ramadan cinical assessment | Mean change HbA1c level |
Countries
United Kingdom
Outcome results
None listed