Trial for People With Established Type 2 Diabetes During Ramadan
Information source: University of Leicester
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Liraglutide (Drug); Liraglutide (Drug); Sulfonylurea or Pioglitazone (Drug); Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Leicester Official(s) and/or principal investigator(s): Melanie J D, Principal Investigator, Affiliation: University of Leicester
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.
Clinical Details
Official title: A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Liraglutide vs. a Sulphonylurea
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Composite
Secondary outcome: HbA1c only
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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 and Contacts
University Hospitals of Leicester, Leicester, Leicestershire, United Kingdom
University Hospital Birmingham, Birmingham, West Midlands, United Kingdom
Additional Information
Starting date: April 2011
Last updated: November 14, 2014
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