A Study of LY2189102 in Patients With Type 2 Diabetes
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 20 - 75 |
Updated: | 4/17/2018 |
Start Date: | June 2009 |
End Date: | November 2010 |
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.
Study to evaluate the safety, tolerability and efficacy of LY2189102 in patients with type 2
diabetes.
diabetes.
Inclusion Criteria:
- 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 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 (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.
We found this trial at
18
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