A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.

Sponsor
Novo Nordisk A/S
Study ID
NCT02607306
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • insulin degludec/liraglutide — DRUG
    Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
  • insulin degludec — DRUG
    Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
  • liraglutide — DRUG
    Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.

Study Details

This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with type 2 diabetes mellitus.

Key Dates

Start date
Nov 18, 2015
Status verified
Mar 2021
Primary completion
Dec 15, 2017
Completion
Dec 22, 2017

Study Design

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

Arms

  • Experimental: Insulin degludec/liraglutide OD
  • Active Comparator: Insulin degludec OD
  • Active Comparator: Liraglutide OD

Primary Outcome Measure

Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira [ Time Frame: Week 0, Week 52 ]

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