Status:
COMPLETED
A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed to evaluate the pharmacokinetics, tolerability, and safety of exenatide once weekly suspension in both healthy subjects and in subjects with type 2 diabetes. The study will also...
Eligibility Criteria
Inclusion
- Cohort 1:
- Is 19 to 65 years old
- Has a body mass index (BMI) of 23 kg/m2 to 35 kg/m2, inclusive, at study start
- Cohort 2:
- Is 19 to 75 years old
- Has been diagnosed with type 2 diabetes mellitus
- Has HbA1c of 7.1% to 10.0%, inclusive, at study start
- Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at study start
- Has been treated with diet and exercise alone or with a stable regimen of metformin, a TZD, or a combination of metformin and a TZD, for a minimum of 2 months prior to study start
- Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
- Hormone replacement therapy (female subjects)
- Oral contraceptives (female subjects)
- Antihypertensive agents
- Lipid-lowering agents
- Thyroid replacement therapy
- Antidepressant agents
Exclusion
- Cohort 1:
- Has a personal history of diabetes mellitus (including impaired glucose tolerance, impaired fasting glucose, or gestational diabetes)
- Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start
- Has ever been exposed to exenatide (BYETTA, exenatide once weekly, or any other formulation of exenatide) or any GLP 1 analog
- Cohort 2:
- Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start
- Has ever been exposed to exenatide (BYETTA, exenatide once weekly, or any other formulation of exenatide) or any GLP 1 analog
- Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
- Any DPP-4 inhibitor or sulfonylurea (SU) within 3 months prior to study start
- Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days prior to study start
- Insulin within 2 weeks prior to study start or for more than 1 week within 3 months prior to study start
- Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
- Prescription or over-the-counter weight loss medications within 3 months prior to study start
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00894322
Start Date
April 1 2009
End Date
August 1 2009
Last Update
September 18 2015
Active Locations (1)
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1
Research Site
Lincoln, Nebraska, United States