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

January 26, 2017 updated by: Novo Nordisk A/S

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™)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

368

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 101200
        • Novo Nordisk Investigational Site
    • Beijing
      • Beijing, Beijing, China, 100071
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100853
        • Novo Nordisk Investigational Site
      • Beijing, Beijing, China, 100700
        • Novo Nordisk Investigational Site
    • Chongqing
      • ChongQing, Chongqing, China, 404000
        • Novo Nordisk Investigational Site
    • Hebei
      • 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
        • Novo Nordisk Investigational Site
    • Jiangsu
      • 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
        • Novo Nordisk Investigational Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Novo Nordisk Investigational Site
    • Jilin
      • Changchun, Jilin, China, 130041
        • Novo Nordisk Investigational Site
    • Liaoning
      • Dalian, Liaoning, China, 116033
        • Novo Nordisk Investigational Site
      • Shenyang, Liaoning, China, 110021
        • Novo Nordisk Investigational Site
    • Shandong
      • Qingdao, Shandong, China, 266003
        • Novo Nordisk Investigational Site
    • Shanghai
      • Shanghai, Shanghai, China, 200240
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 201199
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200120
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200080
        • Novo Nordisk Investigational Site
      • Shanghai, Shanghai, China, 200092
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0, week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0, week 26
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.
Week 0, week 26
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
After 26 weeks of treatment
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
After 26 weeks of treatment
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
Weeks 0-26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-4075
  • U1111-1139-0016 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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