Status:
COMPLETED
A Study of LY2189102 in Patients With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
Study to evaluate the safety, tolerability and efficacy of LY2189102 in patients with type 2 diabetes.
Eligibility Criteria
Inclusion
- Have Type 2 Diabetes and confirmed by fasting C-peptide levels greater than or equal to 0.8 nanograms per milliliter \[ng/ml\]), with duration of more than 3 months.
- Body mass index between 25 and 40 kilograms per square meter (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 2 milligrams per liter (mg/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
- 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 (100 mg 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, (for example, 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 human immunodeficiency virus (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 milligrams per deciliter (mg/dL).
- Serum aspartate 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 (for example, 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 the patient at serious risk.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00942188
Start Date
June 1 2009
End Date
November 1 2010
Last Update
September 18 2019
Active Locations (18)
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1
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
2
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
3
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
4
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