Overview
The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes
Status:
Completed
Completed
Trial end date:
2014-11-01
2014-11-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of liraglutide compared to sitagliptin, both as add-on to metformin in Chinese subjects with type 2 diabetes inadequately controlled on metformin monotherapy. Eligible subjects will continue their metformin background treatment during the trial.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novo Nordisk A/STreatments:
Liraglutide
Metformin
Sitagliptin Phosphate
Criteria
Inclusion Criteria:- Male or female, age at least 18 years and below 80 years at the time of signing
informed consent
- Subjects diagnosed type 2 diabetes mellitus and treated with metformin monotherapy at
a stable dose of at least 1500 mg daily or maximum tolerated dose above or equal to
1000 mg daily for at least 60 days prior to screening
- HbA1c 7.0-10.0% (both inclusive)
- Body mass index below or equal to 45.0 kg/m^2
Exclusion Criteria:
- Treatment with glucose lowering agent(s) other than stated in the inclusion criteria
in a period of 60 days prior to screening. An exception is short-term treatment (below
or equal to 7 days in total) with insulin in connection with intercurrent illness
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Any chronic disorder or severe disease which at the discretion of the investigator
might jeopardise subject's safety or compliance with the protocol
- Screening calcitonin value above or equal to 50 ng/l
- Personal or family history of medullary thyroid carcinoma or multiple endocrine
neoplasia syndrome type 2
- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer
or squamous cell skin cancer)
- Any contraindications to liraglutide, sitagliptin or metformin according to local
labelling