Trial for People With Established Type 2 Diabetes During Ramadan

University of Leicester99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes

Interventions

LiraglutideDRUG

4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response

LiraglutideDRUG

4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response.

Sulfonylurea or PioglitazoneDRUG

Addition to Metformin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospitals of Leicester

Leicester, Leicestershire, United Kingdom

University Hospital Birmingham

Birmingham, West Midlands, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

HbA1c only

Mean change HbA1c level

Time frame: same as primary, 12 weeks following post Ramadan cinical assessment

Data from ClinicalTrials.gov

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