Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

Sponsor
Novo Nordisk A/S
Study ID
NCT01512108
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • liraglutide — DRUG
    0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).
  • oral anti-diabetic drug — DRUG
    An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose.

Study Details

This trial was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.

Key Dates

Start date
Jan 10, 2012
Status verified
Nov 2017
Primary completion
Apr 26, 2013
Completion
Apr 26, 2013

Study Design

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

Arms

  • Experimental: Liraglutide + an OAD therapy
  • Active Comparator: Two OADs combination therapy

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 52 + 7 days ]

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