NCT01001104

Brief Summary

The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2009

Typical duration for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

September 28, 2015

Completed
Last Updated

September 28, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

October 22, 2009

Results QC Date

October 3, 2014

Last Update Submit

August 28, 2015

Conditions

Diabetes Mellitus, Type 2

Keywords

Metabolic DiseasesGlucose Metabolism DisordersDiabetesGLP-1Lilly

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks

    Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect.

    Baseline, 12 weeks

Secondary Outcomes (9)

  • Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks

    up to 12 weeks

  • Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks

    up to 12 weeks

  • Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks

    Baseline, 12 weeks

  • Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks

    Baseline, 12 weeks

  • Change From Baseline in Total Body Weight at 12 Weeks

    Baseline, 12 weeks

  • +4 more secondary outcomes

Study Arms (4)

0.75 mg LY2189265

EXPERIMENTAL
Drug: LY2189265

0.5 mg LY2189265

EXPERIMENTAL
Drug: LY2189265

0.25 mg LY2189265

EXPERIMENTAL
Drug: LY2189265

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LY2189265DRUG

Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.

0.25 mg LY21892650.5 mg LY21892650.75 mg LY2189265
PlaceboDRUG

Administered by SC injection, QW for 12 weeks.

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese patients with type 2 diabetes with a body mass index (BMI)≥18.5 kilograms per square meter (kg/m\^2) but \<40.0 kg/m\^2.
  • Patients who are oral antidiabetic drug (OAD) naïve or are taking OAD monotherapy except for a dipeptidyl peptidase-4 inhibitor (DPP-IV) and are willing to discontinue their OAD.
  • Patients who are OAD naïve with screening glycosylated hemoglobin (HbA1c) value of 7.0% to 9.5% and randomization HbA1c value of 7.0% to 9.5%, or who are taking OAD monotherapy with screening HbA1c value of 6.0% to 8.5% and randomization HbA1c value of 7.0% to 9.5%.
  • Patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening.

You may not qualify if:

  • Patients who are currently taking prescription medications to promote weight loss
  • Patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening.
  • Patients who have a known clinically significant gastrointestinal disorder, have undergone excision of all or any part of the gastrointestinal tract, have undergone gastric bypass surgery for treatment of obesity, or chronically take drugs that directly influence gastrointestinal motility.
  • Patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension.
  • Patients who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis. Patients who have amylase and/or lipase of 1.5 times or more the upper limit of the reference range.
  • Have a family history, obvious clinical signs, or symptoms of medullary carcinoma of thyroid.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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, 276-0049, Japan

Location

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, 359-1161, Japan

Location

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.

Kochi, 781-8555, Japan

Location

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, 604-8151, Japan

Location

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, 530-0047, Japan

Location

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, 171-0021, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 23, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 28, 2015

Results First Posted

September 28, 2015

Record last verified: 2015-08

Locations

JP(6)