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| Name | Class |
|---|---|
| University Hospitals, Leicester | OTHER |
| University Hospital Birmingham | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy 2 | Active Comparator | addition of Sulfonylurea or Pioglitazone to Metformin |
|
| Dual Therapy 1 | Experimental | Swap Liraglutide for sulfonylurea or pioglitazone taken as second line therapy (Metformin) first line) |
|
| Dual therapy 2 | Active Comparator | Maintain sulfonylurea or pioglitazone as second line therapy (Metformin first line) |
|
| Monotherapy | Experimental | Addition of Liraglutide to Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | 4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c only | Mean change HbA1c level | same as primary, 12 weeks following post Ramadan cinical assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie J D | University of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leicester | Leicester | Leicestershire | United Kingdom | |||
| University Hospital Birmingham |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D013453 | Sulfonylurea Compounds |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Liraglutide | Drug | 4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response. |
|
|
| Sulfonylurea or Pioglitazone | Drug | Addition to Metformin |
|
| Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide | Drug | As per clinical guidelines for prescription |
|
| Birmingham |
| West Midlands |
| United Kingdom |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |