The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT02008682
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Administered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose.
  • sitagliptin — DRUG
    Administered orally once daily as add-on to the subject's stable pre-trial metformin dose.

Study Details

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of liraglutide compared to sitagliptin, both as add-on to metformin in Chinese subjects with type 2 diabetes inadequately controlled on metformin monotherapy. Eligible subjects will continue their metformin background treatment during the trial.

Key Dates

Start date
Dec 31, 2013
Status verified
Jan 2017
Primary completion
Nov 30, 2014
Completion
Nov 30, 2014

Study Design

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

Arms

  • Experimental: Liraglutide 1.8 mg + metformin
    2-week screening period, 26-week treatment duration, and a 1-week follow-up period
  • Active Comparator: Sitagliptin 100 mg + metformin
    2-week screening period, 26-week treatment duration, and a 1-week follow-up period

Primary Outcome Measure

Change From Baseline in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, week 26 ]

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