Trial for People With Established Type 2 Diabetes During Ramadan

Sponsor
University of Leicester
Study ID
NCT02292290
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 30, 2011
Status verified
Aug 2012
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

Enrollment
99 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Monotherapy 2
    addition of Sulfonylurea or Pioglitazone to Metformin
  • Experimental: Dual Therapy 1
    Swap Liraglutide for sulfonylurea or pioglitazone taken as second line therapy (Metformin) first line)
  • Active Comparator: Dual therapy 2
    Maintain sulfonylurea or pioglitazone as second line therapy (Metformin first line)
  • Experimental: Monotherapy
    Addition of Liraglutide to Metformin

Primary Outcome Measure

Composite [ Time Frame: 12 weeks following post Ramadan cinical assessment ]

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