The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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™)

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: liraglutide
* Drug: sitagliptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide 1.8 mg + metformin<br>2-week screening period, 26-week treatment duration, and a 1-week follow-up period | Drug: liraglutide<br>* Administered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose.<br>|
| Active Comparator: Sitagliptin 100 mg + metformin<br>2-week screening period, 26-week treatment duration, and a 1-week follow-up period | Drug: sitagliptin<br>* Administered orally once daily as add-on to the subject's stable pre-trial metformin dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Glycosylated Haemoglobin (HbA1c) | Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26. | Week 0, week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Plasma Glucose | Mean change from baseline in fasting plasma glucose (FPG) at Week 26. | Week 0, week 26 | 
| Change From Baseline in 7-point Self-measured Plasma Glucose Profile | Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time. | Week 0, week 26 | 
| Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target) | Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26 | After 26 weeks of treatment | 
| Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target) | Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26 | After 26 weeks of treatment | 
| Number of Confirmed Hypoglycaemic Episodes | confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L | Weeks 0-26 |