Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT01930188
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • semaglutide — DRUG
    For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.
  • sitagliptin — DRUG
    Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
  • placebo — DRUG
    Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
  • placebo — DRUG
    For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.

Study Details

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.

Key Dates

Start date
Dec 2, 2013
Status verified
May 2019
Primary completion
Oct 12, 2015
Completion
Oct 12, 2015

Study Design

Enrollment
1,231 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide 0.5 mg + sitagliptin placebo
  • Experimental: Semaglutide 1.0 mg + sitagliptin placebo
  • Active Comparator: Sitagliptin 100 mg + semaglutide placebo 1.0 mg
  • Active Comparator: Sitagliptin 100 mg + semaglutide placebo 0.5 mg

Primary Outcome Measure

Change in HbA1c (Glycosylated Haemoglobin) From Baseline [ Time Frame: Week 0, week 56 ]

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