This trial was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
363
0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).
An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose.
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan
Novo Nordisk Investigational Site
Ehime, Japan, Japan
Novo Nordisk Investigational Site
Fukuoka, Japan
Novo Nordisk Investigational Site
Fukuoka, Japan
Novo Nordisk Investigational Site
Incidence of Treatment Emergent Adverse Events (AEs)
Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.
Time frame: Week 0 to Week 52 + 7 days
Number of Confirmed Hypoglycaemic Episodes
Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes \[An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose \<3.1 mmol/L (56 mg/dL) or full blood glucose \<2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value \<3.1 mmol/L (56 mg/dL) or full blood glucose value \<2.8 mmol/L (50 mg/dL)\] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL).
Time frame: Week 0 to Week 52
Change in HbA1c From Baseline to Week 52
Estimated mean change in HbA1c from baseline after 52 Weeks of treatment
Time frame: Week 0, week 52
Change in FPG From Baseline to Week 52
Estimated mean change from baseline in FPG after 52 Weeks of treatment
Time frame: Week 0, week 52
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Fukuoka, Japan
Novo Nordisk Investigational Site
Fukuoka, Japan, Japan
Novo Nordisk Investigational Site
Fukuoka-shi, Fukuoka, Japan
Novo Nordisk Investigational Site
Kamagaya-shi, Chiba, Japan
Novo Nordisk Investigational Site
Kashiwara-shi, Osaka, Japan
...and 26 more locations