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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014