T4R: Trial for People With Established Type 2 Diabetes During Ramadan

Sponsor

University of Leicester (Other)

Overall Status

Completed

CT.gov ID

NCT02292290

Collaborator

University Hospitals, Leicester (Other), University Hospital Birmingham (Other)

Enrollment

Locations

Arms

Duration (Months)

49.5

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Liraglutide Drug: Liraglutide Drug: Sulfonylurea or Pioglitazone Drug: Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

HbA1c only [same as primary, 12 weeks following post Ramadan cinical assessment]
Mean change HbA1c level

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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