A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 19 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | April 2009 |
| End Date: | August 2009 |
A Two-Cohort, Single- and Repeat Dose Study to Examine the Pharmacokinetics, Tolerability, and Safety of Ready to Use Exenatide Once Weekly in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus
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 evaluate efficacy in the type 2 diabetes patients. Development
of this exenatide once weekly presentation would eliminate the need to reconstitute the
product prior to use.
exenatide once weekly suspension in both healthy subjects and in subjects with type 2
diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. Development
of this exenatide once weekly presentation would eliminate the need to reconstitute the
product prior to use.
Inclusion Criteria:
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 Criteria:
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
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