A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• insulin degludec/liraglutide — DRUG
  Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
• insulin glargine — DRUG
  Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
• insulin aspart — DRUG
  Injected s.c./subcutaneously (under the skin) before each main meal.

Study Details

This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.

Key Dates

Start date

Jul 26, 2015

Status verified

Feb 2018

Primary completion

Oct 5, 2016

Completion

Oct 5, 2016

Study Design

Enrollment

506 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: IDegLira
• Active Comparator: IGlar plus IAsp

Primary Outcome Measure

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

Locations (50)

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