A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.

Last updated: July 31, 2018
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Prevention

Diabetic Kidney Disease

Diabetic Macular Edema

Treatment

N/A

Clinical Study ID

NCT02505334
NN2211-4174
U1111-1164-5462
JapicCTI-152975
  • Ages > 20
  • All Genders

Study Summary

This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes mellitus.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female Japanese subjects at least 20 years of age at the time of informedconsent

  • Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior toscreening

  • HbA1c 7.5-10.0% [58 mmol/mol-86 mmol/mol] (both inclusive)

  • Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy isdefined as unchanged medication and unchanged dose) for for at least 60 days beforescreening according to approved Japanese labelling

Exclusion

Exclusion Criteria:

  • Treatment with insulin within 12 weeks prior to screening

  • Treatment with any medication for the indication of diabetes or obesity other thanstated in the inclusion criteria in a period of 60 days before screening

  • Screening calcitonin equal or above 50 ng/l

  • History of pancreatitis (acute or chronic)

  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrineneoplasia type 2 (MEN 2)

  • Subjects presently classified as being in New York Heart Association (NYHA) Class IV

  • Within the past 180 days any of the following: myocardial infarction, stroke orhospitalisation for unstable angina and/or transient ischemic attack

  • Diagnosis of malignant neoplasms within the last 5 years (except basal and squamouscell skin cancer, polyps and in-situ carcinomas)

  • Any condition which, in the opinion of the investigator might jeopardise subject'ssafety or compliance with the protocol

Study Design

Total Participants: 635
Study Start date:
July 21, 2015
Estimated Completion Date:
November 09, 2017

Connect with a study center

  • Novo Nordisk Investigational Site

    Annaka-shi, Gunma, 379 0116
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Chitose, Hokkaido, 066-0032
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Chuo-ku Tokyo, 103-0027
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Chuo-ku,, 104 0061
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Chuo-ku, Tokyo, 103 0002
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Fukuoka-shi, Fukuoka,
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Higashiosaka-shi, Osaka,
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Hokkaido, 078-8236
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Ichikawa-shi, Chiba,
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Iruma-shi, Saitama, 358 0011
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Izumisano-shi, 598 0048
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kashiwara-shi, Osaka, 582 0005
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kawagoe-shi, Saitama, 350 0851
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kobe-shi, Hyogo,
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Kumamoto-shi,Kumamoto, 862 0976
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Mito-shi, Ibaraki,
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Miyazaki-shi, 880 0034
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Naka-shi, Ibaraki, 311 0113
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Neyagawa-shi, Osaka,
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Nishinomiya-shi, Hygo, 662 0971
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Nishinomiya-shi, Hyogo, 663-8501
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Oita-shi, 870 0039
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Okawa-shi, Fukuoka, 831 0016
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Osaka-shi, Osaka, 553 0003
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Oyama-shi, Tochigi, 323 0022
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Saga-shi,Saga, 849 0937
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Sapporo-shi, Hokkaido, 060 0062
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Sappro-shi, Hokkaido, 060 8648
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Shimotsuke-shi, Tochigi, 329 0433
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Shinjuku-ku, Tokyo, 160-0008
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Shizuoka-shi, 424 0853
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Suita-shi, Osaka, 565-0853
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Takatsuki-shi, Osaka, 569 1096
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tokyo, 105-8471
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Yokohama, Kanagawa, 236-0004
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Yokohama-shi, 235 0045
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Yokohama-shi Kanagawa, 232-0064
    Japan

    Site Not Available

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