This trial is conducted globally. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,663
Insulin degludec/liraglutide treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). Insulin degludec/liraglutide is injected subcutaneously (under the skin) once daily.
Insulin degludec treatment will be initiated with 10 U and titrated (individually adjusted) twice weekly according to the mean SMPG (fasting). Insulin degludec is injected subcutaneously (under the skin) once daily.
Liraglutide will be started with 0.6 mg and subsequent 0.6 mg weekly dose escalation to 1.8 mg. Liraglutide dose of 1.8 mg/day will be continued for the remaining part of the trial. Liraglutide is injected subcutaneously (under the skin) once daily.
Novo Nordisk Investigational Site
Birmingham, Alabama, United States
Novo Nordisk Investigational Site
Anaheim, California, United States
Novo Nordisk Investigational Site
Bermuda Dunes, California, United States
Novo Nordisk Investigational Site
Concord, California, United States
Novo Nordisk Investigational Site
Encino, California, United States
Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.
Values of mean change in HbA1c.
Time frame: Week 0, week 26
Mean Change From Baseline in Body Weight at Week 26
Values of mean change in body weight.
Time frame: Week 0, Week 26
Number of Hypoglycaemic Episodes
Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.
Time frame: Weeks 0-26
Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test
Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.
Time frame: Week 0, Week 26
Mean Actual Daily Insulin Dose
Mean of the actual doses recorded at visit 28 (Week 26).
Time frame: Week 26
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Novo Nordisk Investigational Site
Fair Oaks, California, United States
Novo Nordisk Investigational Site
Fresno, California, United States
Novo Nordisk Investigational Site
Greenbrae, California, United States
Novo Nordisk Investigational Site
La Jolla, California, United States
Novo Nordisk Investigational Site
Long Beach, California, United States
...and 292 more locations