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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

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ClinicalTrials.gov Identifier: NCT02008682
Recruitment Status : Completed
First Posted : December 11, 2013
Results First Posted : December 22, 2015
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: sitagliptin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, week 26 ]
    Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.


Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose [ Time Frame: Week 0, week 26 ]
    Mean change from baseline in fasting plasma glucose (FPG) at Week 26.

  2. Change From Baseline in 7-point Self-measured Plasma Glucose Profile [ Time Frame: Week 0, week 26 ]
    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.

  3. Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target) [ Time Frame: After 26 weeks of treatment ]
    Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26

  4. Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target) [ Time Frame: After 26 weeks of treatment ]
    Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26

  5. Number of Confirmed Hypoglycaemic Episodes [ Time Frame: Weeks 0-26 ]
    confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008682


Locations
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China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100071
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100700
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100853
China, Chongqing
Novo Nordisk Investigational Site
ChongQing, Chongqing, China, 404000
China, Hebei
Novo Nordisk Investigational Site
Cangzhou, Hebei, China, 061000
Novo Nordisk Investigational Site
Hengshui, Hebei, China, 053000
Novo Nordisk Investigational Site
Shijiazhuang, Hebei, China, 050000
Novo Nordisk Investigational Site
Shijiazhuang, Hebei, China, 050051
China, Jiangsu
Novo Nordisk Investigational Site
Nanjing, Jiangsu, China, 210011
Novo Nordisk Investigational Site
Nanjing, Jiangsu, China, 210012
Novo Nordisk Investigational Site
Nanjing, Jiangsu, China, 210029
Novo Nordisk Investigational Site
Suzhou, Jiangsu, China, 215004
Novo Nordisk Investigational Site
Wuxi, Jiangsu, China, 214023
Novo Nordisk Investigational Site
Zhenjiang, Jiangsu, China, 212001
China, Jiangxi
Novo Nordisk Investigational Site
Nanchang, Jiangxi, China, 330006
China, Jilin
Novo Nordisk Investigational Site
Changchun, Jilin, China, 130041
China, Liaoning
Novo Nordisk Investigational Site
Dalian, Liaoning, China, 116033
Novo Nordisk Investigational Site
Shenyang, Liaoning, China, 110021
China, Shandong
Novo Nordisk Investigational Site
Qingdao, Shandong, China, 266003
China, Shanghai
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200080
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200092
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200120
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200240
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 201199
China
Novo Nordisk Investigational Site
Beijing, China, 101200
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02008682    
Other Study ID Numbers: NN2211-4075
U1111-1139-0016 ( Other Identifier: WHO )
First Posted: December 11, 2013    Key Record Dates
Results First Posted: December 22, 2015
Last Update Posted: March 9, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Liraglutide
Hypoglycemic Agents
 Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action