A Study of LY2189265 in Japanese Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01001104
First received: October 22, 2009
Last updated: April 5, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2189265
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Japanese Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change in glycosylated hemoglobin (HbA1c) from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving glycosylated hemoglobin (HbA1c) < 7% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving glycosylated hemoglobin (HbA1c) < 6.5% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in fasting blood glucose values (FBG) from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change in mean daily blood glucose (based on Self monitoring blood glucose) from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change in total body weight from baseline to 12 weeks endpoint [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in insulin sensitivity (HOMA2-S) using the updated Homeostasis Model Assessment (HOMA2) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Beta-cell function (HOMA2-B) using the updated Homeostasis Model Assessment (HOMA2) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics Cmax [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Incidence of Self-reported hypoglycemic episodes [ Time Frame: 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 145
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.75mg LY2189265 Drug: LY2189265
Administered by subcutaneous injection, once weekly for 12 weeks
Experimental: 0.5mg LY2189265 Drug: LY2189265
Administered by subcutaneous injection, once weekly for 12 weeks
Experimental: 0.25mg LY2189265 Drug: LY2189265
Administered by subcutaneous injection, once weekly for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Administered by subcutaneous injection, once weekly for 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese patients with type 2 diabetes with a body mass index of 18.5kg/m2 to 40.0kg/m2.
  • 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 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.

Exclusion Criteria:

  • Patients who are currently taking ethical 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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001104

Locations
Japan
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, Japan, 276-0049
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, Japan, 359-1161
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, Japan, 781-8555
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, Japan, 604-8151
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, Japan, 530-0047
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, Japan, 171-0021
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT01001104     History of Changes
Other Study ID Numbers: 12840, H9X-JE-GBCZ
Study First Received: October 22, 2009
Last Updated: April 5, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eli Lilly and Company:
Metabolic Diseases
Glucose Metabolism Disorders
Diabetes
GLP-1
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014