Clinical trial NCT02008682: The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes
Official title: The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes.(LIRA-DPP-4 CHINA™)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-12-11
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Glycosylated Haemoglobin (HbA1c)
timeFrame: Week 0, week 26
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose
timeFrame: Week 0, week 26
measure: Change From Baseline in 7-point Self-measured Plasma Glucose Profile
timeFrame: Week 0, week 26
measure: Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)
timeFrame: After 26 weeks of treatment
measure: Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)
timeFrame: After 26 weeks of treatment
measure: Number of Confirmed Hypoglycaemic Episodes
timeFrame: Weeks 0-26
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: ChongQing
country: China
facility: Novo Nordisk Investigational Site
state: Chongqing
city: Cangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Hebei
city: Hengshui
country: China
facility: Novo Nordisk Investigational Site
state: Hebei
city: Shijiazhuang
country: China
facility: Novo Nordisk Investigational Site
state: Hebei
city: Shijiazhuang
country: China
facility: Novo Nordisk Investigational Site
state: Hebei
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Suzhou
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Wuxi
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Zhenjiang
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Nanchang
country: China
facility: Novo Nordisk Investigational Site
state: Jiangxi
city: Changchun
country: China
facility: Novo Nordisk Investigational Site
state: Jilin
city: Dalian
country: China
facility: Novo Nordisk Investigational Site
state: Liaoning
city: Shenyang
country: China
facility: Novo Nordisk Investigational Site
state: Liaoning
city: Qingdao
country: China
facility: Novo Nordisk Investigational Site
state: Shandong
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Zang L, Liu Y, Geng J, Luo Y, Bian F, Lv X, Yang J, Liu J, Peng Y, Li Y, Sun Y, Bosch-Traberg H, Mu Y. Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26-week, open-label, randomized, active comparator clinical trial. Diabetes Obes Metab. 2016 Aug;18(8):803-11. doi: 10.1111/dom.12674. Epub 2016 May 20.