A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension

Study identifier:BCB110

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1/2

Healthy volunteers

Study drug

exenatide once weekly

Sex

All

Actual Enrollment

Study type

Interventional

Age

19 Years - 75 Years

Date

Study Start Date: 01 Apr 2009

Primary Completion Date: 01 Aug 2009

Study Completion Date: 01 Aug 2009

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2015 by AstraZeneca Pharmaceuticals

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

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

No locations available

Arms	Assigned Interventions
Experimental: Cohort 1 Healthy Participants Single 10 mg Exenatide A single 10-mg dose of exenatide once weekly suspension given to healthy participants via 3 subcutaneous (SC) injections at Day 1.	Drug: exenatide once weekly subcutaneous injection, 10.0 mg, single injection
Experimental: Cohort 2 Diabetes Participants Exenatide 2 mg On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, thiazolidinedione (TZD), or a combination of metformin or TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks.	Drug: exenatide once weekly subcutaneous injection, 2.0 mg, once a week for 12 weeks
Placebo Comparator: Cohort 2 Diabetes Participants Placebo On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, thiazolidinedione (TZD), or a combination of metformin or TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks.	Other: Placebo subcutaneous injection, volume equivalent to Cohort 2 experimental intervention, once a week for 12 weeks

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

Amylin Call Center

800-349-8919

Investigators

Principal Investigator

Vice President, Clinical Development

Amylin Pharmaceuticals