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
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 April 16, 2014