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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

Page last updated: August 23, 2015

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