A Study of LY3025876 in Participants With Diabetes
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 21 - 70 |
Updated: | 1/26/2019 |
Start Date: | June 2013 |
End Date: | December 2014 |
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3025876 in Patients With Type 2 Diabetes Mellitus
The main purpose of this study is to assess the safety and tolerability of LY3025876 given
alone (Part A) and in combination with liraglutide (Part B) in participants with type 2
diabetes mellitus (T2DM).
alone (Part A) and in combination with liraglutide (Part B) in participants with type 2
diabetes mellitus (T2DM).
This study will also evaluate how much of the study drug enters the blood stream and how long
it takes for the body to remove the study drug. Information about any side effects that may
occur will also be collected. Participants will continue their usual diet and exercise
program and may remain on their physician-prescribed dose of metformin.
Each part of the study is expected to last 10 to 12 weeks on average, not including
screening. Participants may only enroll in one part.
it takes for the body to remove the study drug. Information about any side effects that may
occur will also be collected. Participants will continue their usual diet and exercise
program and may remain on their physician-prescribed dose of metformin.
Each part of the study is expected to last 10 to 12 weeks on average, not including
screening. Participants may only enroll in one part.
Inclusion Criteria:
- Diagnosis of type 2 diabetes mellitus (T2DM) as determined by the investigator,
controlled with diet or exercise alone or on a stable dose of metformin for at least
30 days
- Have a body mass index (BMI) greater than or equal to 23 and less than or equal to 45
kilograms per square meter (kg/m^2) at screening
- Have a supine blood pressure reading at screening of between 90-160 millimeter of
mercury (mmHg) (systolic) and 40-95 mmHg (diastolic)
- Women not of child-bearing potential due to surgical sterilization (hysterectomy or
bilateral oophorectomy or tubal ligation) or menopause
Exclusion Criteria:
- Have taken LY3025876 or investigational drugs like it (for example, other fibroblast
growth factor-21 [FGF21]-related drugs) or have known allergies to these drugs
- History or presence of bone disease (including osteoporosis or unhealed fractures)
- Current active treatment of periodontal disease
- Have had a significant change in weight, defined as a gain or loss of at least 4
kilogram (kg) (9 pounds) in the last 3 months
- Have had greater than 1 episode of severe hypoglycemia within 6 months of screening
that required the assistance of another person to actively administer carbohydrate,
glucagon, or other resuscitative actions or had a seizure or coma
- Have known allergies or a history of intolerance to liraglutide, glucagon-like peptide
1 (GLP-1) analogues, or other related compounds
- Have a history of acute or chronic pancreatitis
- Have a personal or family history of medullary thyroid carcinoma or have multiple
endocrine neoplasia syndrome type 2
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