Trial for People With Established Type 2 Diabetes During Ramadan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy 2

addition of Sulfonylurea or Pioglitazone to Metformin

Group Type ACTIVE_COMPARATOR

Sulfonylurea or Pioglitazone

Intervention Type DRUG

Addition to Metformin

Dual Therapy 1

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

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

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

Dual therapy 2

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

As per clinical guidelines for prescription

Monotherapy

Addition of Liraglutide to Metformin

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

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

Interventions

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Liraglutide

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

Intervention Type DRUG

Liraglutide

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

Intervention Type DRUG

Sulfonylurea or Pioglitazone

Addition to Metformin

Intervention Type DRUG

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

As per clinical guidelines for prescription

Intervention Type DRUG

Other Intervention Names

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Victoza Victoza

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No