Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT01917656
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    1.8 mg administered subcutaneously (s.c., under the skin) once daily
  • metformin — DRUG
    Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged
  • sulphonylurea — DRUG
    Subjects will continue on their pre-trial SU tablet treatment, doses unchanged

Study Details

This trial is conducted in Africa and Asia. The aim of the trial is to investigate the efficacy and safety of liraglutide versus sulphonylurea (SU) both in combination with metformin during Ramadan in subjects with type 2 diabetes (T2DM).

Key Dates

Start date
Jan 9, 2014
Status verified
Jul 2017
Primary completion
Sep 1, 2014
Completion
Sep 4, 2014

Study Design

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

Arms

  • Experimental: Liraglutide+Metformin
    Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
  • Active Comparator: Sulphonylurea and Metformin
    Subjects continued on pre-trial sulphonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.

Primary Outcome Measure

Change in Fructosamine From Start of Ramadan to End of Ramadan [ Time Frame: Day -1, day 29 ]

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