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OpenTrials
Completed

NCT Number: NCT02292290

Trial for People With Established Type 2 Diabetes During Ramadan

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals of Leicester, Leicester, Leicestershire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response

Other names: Victoza

Sulfonylurea or Pioglitazone

Drug

Addition to Metformin

Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide

Drug

As per clinical guidelines for prescription

Primary outcomes

  1. Composite

    Time frame: 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 outcomes

  1. HbA1c only

    Time frame: same as primary, 12 weeks following post Ramadan cinical assessment

    Mean change HbA1c level

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • University Hospital Birmingham
  • University Hospitals, Leicester

Registry information

Official study title

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

Acronym: T4R

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 17, 2014
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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