Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.)
Japanese subjects with type 2 diabetes on monotherapy with an OAD (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved Japanese labelling in addition to diet and exercise therapy. Total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to Visit 1
Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months
HbA1c between 7.0-10.0% (both inclusive)
Body Mass Index (BMI) below 40.0 kg/m^2
Outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. However, hospitalisation for training of self-injection from Visit 2 that is for no longer than one week is allowed
Subjects able and willing to perform self-monitoring of plasma glucose (SMPG)

Exclusion Criteria

Subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)
Calcitonin above or equal to 160 pg/mL
Personal history of non-familial medullary thyroid carcinoma
Family or personal history of multiple endocrine neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (FMTC)
History of chronic pancreatitis or idiopathic acute pancreatitis
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Treatment with GLP-1 receptor agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor within 12 weeks prior to Visit 1
Having contraindications to liraglutide and any of the OADs (according to Japanese labelling)

Arm && Interventions

Group	Intervention	Description
Two OADs combination therapy	oral anti-diabetic drug	-
Liraglutide + an OAD therapy	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events (AEs)	Week 0 to Week 52 + 7 days	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.

Secondary Outcome Measures

Name	Time	Method
Number of Confirmed Hypoglycaemic Episodes	Week 0 to Week 52	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).
Change in HbA1c From Baseline to Week 52	Week 0, week 52	Estimated mean change in HbA1c from baseline after 52 Weeks of treatment
Change in FPG From Baseline to Week 52	Week 0, week 52	Estimated mean change from baseline in FPG after 52 Weeks of treatment