Trial for People With Established Type 2 Diabetes During Ramadan

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide; Drug: Sulfonylurea or Pioglitazone; Drug: Liraglutide

• Registration Number: NCT02292290
• Lead Sponsor: University of Leicester

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.

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 Timeline

• Study First Submitted: 2011-01-16
• Study Start: 2011-04
• Status Verified: 2012-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-17
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual therapy 2	Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide	Maintain sulfonylurea or pioglitazone as second line therapy (Metformin first line)
Monotherapy 2	Sulfonylurea or Pioglitazone	addition of Sulfonylurea or Pioglitazone to Metformin
Dual Therapy 1	Liraglutide	Swap Liraglutide for sulfonylurea or pioglitazone taken as second line therapy (Metformin) first line)
Monotherapy	Liraglutide	Addition of Liraglutide to Metformin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
HbA1c only	same as primary, 12 weeks following post Ramadan cinical assessment	Mean change HbA1c level

Trial Locations

Locations (2)

University Hospitals of Leicester; 🇬🇧 Leicester, Leicestershire, United Kingdom

University Hospital Birmingham; 🇬🇧 Birmingham, West Midlands, United Kingdom