Trial for People With Established Type 2 Diabetes During Ramadan

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Liraglutide
* Drug: Liraglutide
* Drug: Sulfonylurea or Pioglitazone
* Drug: Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monotherapy 2<br>addition of Sulfonylurea or Pioglitazone to Metformin | Drug: Sulfonylurea or Pioglitazone<br>* Addition to Metformin<br>|
| Experimental: Dual Therapy 1<br>Swap Liraglutide for sulfonylurea or pioglitazone taken as second line therapy (Metformin) first line) | Drug: Liraglutide<br>* 4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response.<br>* Other names: Victoza;|
| Active Comparator: Dual therapy 2<br>Maintain sulfonylurea or pioglitazone as second line therapy (Metformin first line) | Drug: Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide<br>* As per clinical guidelines for prescription<br>|
| Experimental: Monotherapy<br>Addition of Liraglutide to Metformin | Drug: Liraglutide<br>* 4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response<br>* Other names: Victoza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks following post Ramadan cinical assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c only | Mean change HbA1c level | same as primary, 12 weeks following post Ramadan cinical assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Liraglutide, Ramadan, fasting