Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone
Launched by NOVO NORDISK A/S · Jan 13, 2012
Trial Information
Current as of September 29, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- 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)
About Novo Nordisk A/S
Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chuo Ku, Tokyo, Japan
Koriyama Shi, Fukushima, Japan
Kumamoto Shi,Kumamoto, Japan
Yokohama Shi, Japan
Miyazaki Shi, Japan
Naka Shi, Ibaraki, Japan
Ota Ku, Tokyo, Japan
Oyama Shi, Tochigi, Japan
Shizuoka Shi, Japan
Tagajo Shi, Japan
Sapporo Shi, Hokkaido, Japan
Takatsuki Shi, Osaka, Japan
Shimotsuke Shi, Tochigi, Japan
Fukuoka Shi, Fukuoka, Japan
Kashiwara Shi, Osaka, Japan
Kawagoe Shi, Saitama, Japan
Kitakyushu Shi, Fukuoka, Japan
Kurume Shi, Fukuoka, Japan
Okawa Shi, Fukuoka, Japan
Ehime, Japan, Japan
Fukuoka, Japan, Japan
Fukuoka, Japan
Kamagaya Shi, Chiba, Japan
Niigata Shi, Niigata, Japan
Oita, Japan
Osaka Shi, Osaka, Japan
Tochigi, Japan
Tokyo, Japan
Yamaguchi, Japan
Patients applied
Trial Officials
Global Clinical Registry (GCR, 1452)
Study Director
Novo Nordisk A/S
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials