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

University of Leicester

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Liraglutide; Drug: Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide; Drug: Sulfonylurea or Pioglitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT02292290

0207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 4 patient groups

Monotherapy 2

Active Comparator group

Description:

addition of Sulfonylurea or Pioglitazone to Metformin

Treatment:

Drug: Sulfonylurea or Pioglitazone

Dual Therapy 1

Experimental group

Description:

Swap Liraglutide for sulfonylurea or pioglitazone taken as second line therapy (Metformin) first line)

Treatment:

Drug: Liraglutide

Drug: Liraglutide

Dual therapy 2

Active Comparator group

Description:

Maintain sulfonylurea or pioglitazone as second line therapy (Metformin first line)

Treatment:

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

Monotherapy

Experimental group

Description:

Addition of Liraglutide to Metformin

Treatment:

Drug: Liraglutide

Drug: Liraglutide