A Study of LY2189102 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00942188
First received: July 17, 2009
Last updated: April 5, 2011
Last verified: December 2010
  Purpose

Study to evaluate the safety, tolerability and efficacy of LY2189102 in patients with type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes
Drug: LY2189102
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: Phase 2 Randomized, Double-blind, Placebo Controlled, Parallel Design Study in Patients With Type 2 Diabetes Mellitus Who Are Stable on Diet and Exercise, With or Without Metformin Monotherapy.

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 12 weeks in Glycosylated Hemoglobin (HbA1c). [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline to 12 weeks in fasting glucose. [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 12 weeks in insulin sensitivity. [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 weeks in beta-cell function measured by glucose and insulin changes with the Mixed Meal Tolerance Test (MMTT). [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 weeks in Pharmacokinetics Cmax. [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change at week 10 and week 12 in HBA1c [ Time Frame: week 10, week 12 ] [ Designated as safety issue: No ]
  • Change from baseline to 12 weeks in Pharmacokinetics Area Under the Concentration Time Curve (AUC). [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 12 weeks in Pharmacokinetics measured by serum concentration. [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: June 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.6mg LY2189102 Drug: LY2189102
2 subcutaneous injections weekly for 12 weeks.
Experimental: 18mg LY2189102 Drug: LY2189102
2 subcutaneous injections weekly for 12 weeks.
Experimental: 180mg LY2189102 Drug: LY2189102
2 subcutaneous injections weekly for 12 weeks.
Placebo Comparator: Placebo
0.9% Sodium Chloride
Drug: Placebo
2 subcutaneous injections 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:

  • Have Type 2 Diabetes and confirmed by fasting C-peptide levels greater than or equal to 0.8 ng/ml), with duration of more than 3 months.
  • Body mass index between 25 and 40 kg/m2.
  • Stable on diet and exercise alone, with or without metformin monotherapy (stable regimen or dose for at least 8 weeks).
  • Drug-naïve or previous anti-diabetic pharmacotherapy use is allowed (for the latter, patient must have stopped taking pharmacotherapy greater than 12 weeks prior to screening and only if deemed appropriate by the investigator).
  • Angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, thiazide diuretics or calcium channel blockers are permitted for the treatment of hypertension or proteinuria.
  • Glycated hemoglobin level between 7% and 10%.
  • Baseline High-sensitivity C-reactive protein greater than or equal to 2mg/L
  • Females of childbearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must test negative for pregnancy at the time of enrollment based on a pregnancy test. Furthermore, sexually active female and male participants must agree to use 2 reliable methods of birth control during the study and for 3 months following the last dose of study drug.
  • Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

Exclusion Criteria:

  • Current use of anti-diabetic pharmacotherapy (except metformin, under conditions specified in Inclusion Criteria above).
  • Current treatment with anti-inflammatory drugs, including corticosteroids and non-steroidal anti-inflammatory drugs (100mg per day or less of aspirin allowed).
  • Within 60 days of the initial dose of the study drug, have received treatment with a drug that has not received regulatory approval for any indication.
  • Presence of autoantibodies to glutamic acid decarboxylase 65 or islet-cell autoantibody-2.
  • Evidence of tuberculosis as documented by a specific assay, medical history, and chest x-ray. A specific assay, e.g., tuberculin testing, will be conducted unless it is medically inappropriate. Exceptions include patients with a history of a positive specific assay for TB who have been treated with isonicotinyl hydrazine (documented) for at least 6 months, or patients with a previous diagnosis of TB who have been appropriately treated and can provide documentation.
  • Symptomatic herpes zoster within 3 months of randomization.
  • Show evidence of hepatitis C and/or positive hepatitis B surface antigen.
  • Show evidence of human immunodeficiency virus and/or positive test of antibodies to HIV.
  • Received live or attenuated vaccine(s) within the previous 3 months prior to randomization or will receive within 3 months from the end of study.
  • Screening serum creatinine greater than 2.0 mg/dL.
  • Serum Asparate aminotransferase or Alanine aminotransaminase concentration greater than 2x the upper limit of normal.
  • Known allergies to LY2189102 or excipients.
  • Previously completed or withdrawn from this study or any other study investigating LY2189102.
  • Have donated blood of greater than 500 mL within the preceding 30 days and intend to donate within 3 months from the end of study.
  • Have had other recent or ongoing signs of infection (e.g. fever, current treatment with antibiotics).
  • Experienced a serious bacterial infection within 6 months of randomization.
  • Have a serious medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, or neurological disease, or any clinically significant laboratory abnormality.
  • Have had lymphoma, leukemia, or any non-breast malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease.
  • Have had a previous reaction to other biologics that, in the opinion of the investigator, puts patient at serious risk.
  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: NCT00942188

Locations
United States, Alabama
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.
Mobile, Alabama, United States, 36689
United States, California
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.
Anaheim, California, United States, 92801
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.
Chula Vista, California, United States, 91911
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.
La Mesa, California, United States, 91942
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.
Walnut Creek, California, United States, 94598
United States, District of Columbia
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.
Washington, District of Columbia, United States, 20003
United States, Florida
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.
Miami, Florida, United States, 33169
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.
Miami Gardens, Florida, United States, 33169
United States, Idaho
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.
Boise, Idaho, United States, 83702
United States, Maryland
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.
Baltimore, Maryland, United States, 21287
United States, Michigan
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.
Dearborn, Michigan, United States, 48126
United States, Pennsylvania
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.
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
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.
Arlington, Texas, United States, 76014
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.
Dallas, Texas, United States, 75230
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.
San Antonio, Texas, United States, 78229
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.
Tomball, Texas, United States, 77375
United States, Utah
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.
Salt Lake City, Utah, United States, 84107
United States, Virginia
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.
Richmond, Virginia, United States, 23294
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 9 AM - 5 PM 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: NCT00942188     History of Changes
Other Study ID Numbers: 13286, H9C-MC-BBDK
Study First Received: July 17, 2009
Last Updated: April 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Diabetes
Type 2 Diabetes

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

ClinicalTrials.gov processed this record on July 26, 2014