A Study of the Safety and Effectiveness of LY3053102 in Participants With Type 2 Diabetes



Status:Terminated
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - Any
Updated:12/22/2017
Start Date:December 2013
End Date:February 2015

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Safety, Tolerability, Pharmacokinetics, and Efficacy of LY3053102 With 12 Weeks of Treatment in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to investigate the safety and effectiveness of the study drug
known as LY3053102 in participants with Type 2 diabetes mellitus. The study drug will be
given in different doses as an injection under the skin. The study is expected to last up to
6 months for each participant. Participants may remain on stable-dose metformin as prescribed
by their personal physician.


Inclusion Criteria

- Participants with type 2 diabetes mellitus for at least 6 months before entering the
trial based on the disease diagnostic criteria (World Health Organization [WHO])
classification managed with diet or exercise alone or with a stable dose of metformin
of at least 1000 mg/day for at least 60 days before screening or on metformin and an
eligible second oral anti-hyperglycemic medication after a 60-day washout of the
second oral anti-hyperglycemic medication

- Women not of childbearing potential due to surgical sterilization (hysterectomy or
bilateral oophorectomy or tubal ligation) or menopause

- Have a hemoglobin A1c value of ≥7.0% and ≤10.5%, if on diet and exercise or diet,
exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days), or
have a hemoglobin A1c value of ≥7.0% and ≤9.5%, and are on an appropriate diet and
exercise regimen, a stable dose of metformin and willing to discontinue a second oral
anti-hyperglycemic medication

- Have a body mass index ≥23 and ≤45 kilograms per square meter (kg/m^2)

Exclusion Criteria

- Have used insulin for diabetic control for more than 6 consecutive days within 1 year
prior to screening

- Have used thiazolidinediones within 3 months, or any other drugs for treatment of
hyperglycemia (except metformin) within 2 months, prior to the first week of the study

- Have hepatitis B and/or positive hepatitis B surface antigen. hepatitis C or human
immunodeficiency virus (HIV) and/or positive HIV antibodies

- Have known or suspected cardiac autonomic neuropathy (for example, resting tachycardia
or orthostatic hypotension), based on clinical signs, symptoms, or appropriate
diagnostic testing

- Have cardiac disease with functional status that is New York Heart Association Class
II, III, or IV or in the last 6 months have had any of the following: a history of
myocardial infarction , unstable angina, coronary artery bypass graft, percutaneous
coronary intervention (diagnostic angiograms are permitted), transient ischemic
attack, or cerebrovascular accident (for example, stroke)

- Have poorly controlled hypertension, malignant hypertension, renal artery stenosis,
and/or evidence of labile blood pressure including symptomatic postural hypotension.
Doses of antihypertensive medications must be stable for 30 days prior to the first
week of the study

- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis,
or an alanine transaminase or aspartate aminotransferase levels >2 times the upper
limit of the reference range

- Have evidence of hypothyroidism or hyperthyroidism based on clinical evaluation and/or
an abnormal thyroid-stimulating hormone which, in the opinion of the investigator,
would pose a risk to participant safety. Participants on a stable dose of thyroid
replacement therapy may be eligible if they meet the other criteria

- Have clinically significant peripheral vascular disease, or clinical evidence of
active diabetic proliferative retinopathy, (known significant autonomic neuropathy) as
evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or
gastroparesis

- Have an active or untreated malignancy or have been in remission from a clinically
significant malignancy (other than basal or squamous cell skin cancer, in situ
carcinomas of the cervix, or in situ prostate cancer) for less than 5 years

- Have impaired renal function

- Have fasting triglycerides >500 milligrams per deciliter (mg/dL) at screening

- Have experienced a keto-acidotic episode requiring hospitalization in the last 6
months

- Have an electrocardiogram (ECG) considered to be indicative of cardiac disease

- Have personal or family history of long QT syndrome, family history of sudden death in
a first-degree relative before age 40, or personal history of unexplained syncope
within the last year. Use of prescription or over-the-counter medications known to
prolong the QT or QTc interval

- Have a history of bone disease (including osteoporosis or unhealed fractures),
evidence of osteoporosis (femoral neck or lumbar spine T-score <-2.5) determined by
dual X-ray absorptometry (DXA) scan at screening, evidence of osteopenia (T-score
between -1.0 and -2.5 at the femoral neck or lumbar spine) with a high risk of
fracture based on risk factors or current active treatment of periodontal disease
We found this trial at
5
sites
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
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