A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

Last updated: January 16, 2015
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT01468181
13991
H9X-JE-GBDQ
  • Ages > 20
  • All Genders

Study Summary

This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants who have had a diagnosis of type 2 diabetes mellitus before screening

  • Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG,TZD, a-GI or glinides monotherapy for at least 3 months before screening and have beenon a stable dose for at least 8 weeks before screening

  • Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening

  • Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per metersquared (kg/m^2)

Exclusion

Exclusion Criteria:

  • Participants who have a diagnosis of type 1 diabetes

  • Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog within the 3 months before screening

  • Participants who are currently taking insulin or have had previous insulin treatmentwithin the 3 months before screening

  • Participants who have obvious clinical signs or symptoms of pancreatitis, a history ofchronic pancreatitis, or acute pancreatitis at screening, as determined by theinvestigator. Participants who have a serum amylase concentration ≥3 times the upperlimit of the reference range and/or a serum lipase concentration ≥2 times the upperlimit of the reference range, as determined by the central laboratory at screening

  • Participants who have self or family history of medullary C-cell hyperplasia, focalhyperplasia, or medullary thyroid carcinoma (MTC)

Study Design

Total Participants: 394
Study Start date:
November 01, 2011
Estimated Completion Date:
December 31, 2013

Connect with a study center

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Aichi, 466-0815
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Chiba, 277-0825
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Hokkaido, 050-0073
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Hyogo, 662-0971
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Ibaraki, 300-0053
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Kanagawa, 231-0023
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Kyoto, 615-8125
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Nagano, 390-1401
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Okayama, 700-8558
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Osaka, 560-0082
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Saitama, 3438577
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Tokyo, 1030002
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Toyama, 930-0859
    Japan

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Wakayama, 644-0011
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.