A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

Sponsor
Novo Nordisk A/S
Study ID
NCT00696657
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • semaglutide — DRUG
    0.1 mg, once weekly, s.c. injection
  • semaglutide — DRUG
    0.2 mg, once weekly, s.c. injection
  • semaglutide — DRUG
    0.4 mg, once weekly, s.c. injection
  • semaglutide — DRUG
    0.8 mg, once weekly, s.c. injection
  • semaglutide — DRUG
    0.8 mg with titration, once weekly, s.c. injection
  • semaglutide — DRUG
    1.6 mg with titration, once weekly, s.c. injection
  • placebo — DRUG
    0.1 mg, once weekly, s.c. injection
  • placebo — DRUG
    0.2 mg, once weekly, s.c. injection
  • placebo — DRUG
    0.4 mg, once weekly, s.c. injection
  • placebo — DRUG
    0.8 mg with titration, once weekly, s.c. injection
  • placebo — DRUG
    1.6 mg, once weekly, s.c. injection
  • liraglutide — DRUG
    1.2 mg with titration, once daily, s.c. injection
  • liraglutide — DRUG
    1.8 mg with titration, once daily, s.c. injection

Study Details

This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.

Key Dates

Start date
Jun 3, 2008
Status verified
Jul 2019
Primary completion
Feb 5, 2009
Completion
Feb 5, 2009

Study Design

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

Arms

  • Experimental: A
  • Experimental: B
  • Experimental: C
  • Experimental: D
  • Experimental: E
  • Experimental: F
  • Placebo Comparator: G1
  • Placebo Comparator: G2
  • Placebo Comparator: G3
  • Placebo Comparator: G4
  • Placebo Comparator: G5
  • Placebo Comparator: G6
  • Experimental: H
  • Experimental: I

Primary Outcome Measure

HbA1c [ Time Frame: After 12 weeks of treatment. ]

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