Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone
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.
Diabetes Mellitus, Type 2
Drug: oral anti-diabetic drug
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 52-week, Multi-centre, Open-labelled, Randomised (2:1), Parallel-group Trial With an Active Control (Two OADs Combination Therapy) to Evaluate the Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Monotherapy|
- Incidence of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 52 + 7 days ] [ Designated as safety issue: No ]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.
- Number of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 ] [ Designated as safety issue: No ]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 [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]Estimated mean change in HbA1c from baseline after 52 Weeks of treatment
- Change in FPG From Baseline to Week 52 [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]Estimated mean change from baseline in FPG after 52 Weeks of treatment
|Study Start Date:||January 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|Experimental: Liraglutide + an OAD therapy||
0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).
|Active Comparator: Two OADs combination therapy||
Drug: oral anti-diabetic drug
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512108
|Naka-shi, Japan, 311 0113|
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|