Trial for People With Established Type 2 Diabetes During Ramadan (T4R)

January 29, 2020 updated by: University of Leicester

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom
        • University Hospitals of Leicester
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
        • University Hospital Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Monotherapy 2
addition of Sulfonylurea or Pioglitazone to Metformin
Drug: Sulfonylurea or Pioglitazone
Addition to Metformin
EXPERIMENTAL: Dual Therapy 1
Swap Liraglutide for sulfonylurea or pioglitazone taken as second line therapy (Metformin) first line)
Drug: Liraglutide
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response
Other Names:
  • Victoza
Drug: Liraglutide
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response.
Other Names:
  • Victoza
ACTIVE_COMPARATOR: Dual therapy 2
Maintain sulfonylurea or pioglitazone as second line therapy (Metformin first line)
Drug: Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide
As per clinical guidelines for prescription
EXPERIMENTAL: Monotherapy
Addition of Liraglutide to Metformin
Drug: Liraglutide
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response
Other Names:
  • Victoza
Drug: Liraglutide
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response.
Other Names:
  • Victoza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks following post Ramadan cinical assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c only
Time Frame: same as primary, 12 weeks following post Ramadan cinical assessment
Mean change HbA1c level
same as primary, 12 weeks following post Ramadan cinical assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leicester

Collaborators

University Hospitals, Leicester
University Hospital Birmingham

Investigators

  • Principal Investigator: Melanie J D, University of Leicester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

January 16, 2011

First Submitted That Met QC Criteria

November 14, 2014

First Posted (ESTIMATE)

November 17, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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