Trial for People With Established Type 2 Diabetes During Ramadan

Type 2 Diabetes Clinical Trial

— T4R  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292290
• Other study ID #: 0207
• Status: Completed
• Phase: Phase 4
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: August 2012
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Liraglutide
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response
• Liraglutide
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response.
• Sulfonylurea or Pioglitazone
Addition to Metformin
• Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide
As per clinical guidelines for prescription

Locations

Country	Name	City	State
United Kingdom	University Hospital Birmingham	Birmingham	West Midlands
United Kingdom	University Hospitals of Leicester	Leicester	Leicestershire

Sponsors (3)

Lead Sponsor	Collaborator
University of Leicester	University Hospital Birmingham, University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HbA1c only	Mean change HbA1c level	same as primary, 12 weeks following post Ramadan cinical assessment