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Completed

NCT Number: NCT02008682

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Administered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose.

Sitagliptin

Drug

Administered orally once daily as add-on to the subject's stable pre-trial metformin dose.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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™)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2013
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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