Trial for People With Established Type 2 Diabetes During Ramadan
T4R
A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Liraglutide vs. a Sulphonylurea
1 other identifier
interventional
99
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes
Started Apr 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Posted
Study publicly available on registry
November 17, 2014
CompletedJanuary 30, 2020
August 1, 2012
1.7 years
January 16, 2011
January 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
HbA1c only
same as primary, 12 weeks following post Ramadan cinical assessment
Study Arms (4)
Monotherapy 2
ACTIVE COMPARATORaddition of Sulfonylurea or Pioglitazone to Metformin
Dual Therapy 1
EXPERIMENTALSwap Liraglutide for sulfonylurea or pioglitazone taken as second line therapy (Metformin) first line)
Dual therapy 2
ACTIVE COMPARATORMaintain sulfonylurea or pioglitazone as second line therapy (Metformin first line)
Monotherapy
EXPERIMENTALAddition of Liraglutide to Metformin
Interventions
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response
As per clinical guidelines for prescription
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leicesterlead
- University Hospitals, Leicestercollaborator
- University Hospital Birminghamcollaborator
Study Sites (2)
University Hospitals of Leicester
Leicester, Leicestershire, United Kingdom
University Hospital Birmingham
Birmingham, West Midlands, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melanie J D
University of Leicester
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2011
First Posted
November 17, 2014
Study Start
April 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
January 30, 2020
Record last verified: 2012-08