Trial for People With Established Type 2 Diabetes During Ramadan
NCT02292290 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 99
Last updated 2020-01-30
Summary
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.
Conditions
Interventions
- DRUG
-
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response
- DRUG
-
4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response.
- DRUG
-
Sulfonylurea or Pioglitazone
Addition to Metformin
- DRUG
-
Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide
As per clinical guidelines for prescription
Sponsors & Collaborators
-
University Hospitals, Leicester
collaborator OTHER -
University Hospital Birmingham
collaborator OTHER -
University of Leicester
lead OTHER
Principal Investigators
-
Melanie J D · University of Leicester
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- United Kingdom
Study Locations
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