A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs

Sponsor
Novo Nordisk A/S
Study ID
NCT02911948
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
  • Insulin degludec — DRUG
    Injected s.c. / subcutaneously (under the skin) once daily

Study Details

This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide and insulin degludec both in combination with metformin in Japanese subjects with type 2 diabetes mellitus inadequately controlled with basal or pre-mix/combination insulin therapy and oral anti-diabetic drugs.

Key Dates

Start date
Sep 21, 2016
Status verified
Mar 2021
Primary completion
Nov 17, 2017
Completion
Nov 22, 2017

Study Design

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

Arms

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

Primary Outcome Measure

Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: week 0, week 26 ]

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