A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other Oral Antidiabetic Drug (OAD)

Sponsor
Novo Nordisk A/S
Study ID
NCT03175120
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Insulin degludec/liraglutide — DRUG
    Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.
  • Insulin degludec — DRUG
    Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.

Study Details

This trial is conducted in Asia. The aim of this trial is to confirm the superiority of insulin degludec/liraglutide versus insulin degludec in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus after 26 weeks of treatment

Key Dates

Start date
May 26, 2017
Status verified
Mar 2020
Primary completion
Mar 5, 2019
Completion
Apr 4, 2019

Study Design

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

Arms

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

Primary Outcome Measure

Change in HbA1c [ Time Frame: Week 0, week 26 ]

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