Status:
COMPLETED
Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 Jap...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 10 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2013
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT01512108
Start Date
January 10 2012
End Date
April 26 2013
Last Update
December 18 2017
Active Locations (36)
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1
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0002
2
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan, 103 0027
3
Novo Nordisk Investigational Site
Ehime, Japan, Japan, 790 0067
4
Novo Nordisk Investigational Site
Fukuoka, Japan, 812 0025