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

NCT ID: NCT00894322

Last Updated: 2015-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-08-31

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 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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cohort 1: Healthy Participants

A single 10-mg dose of exenatide once weekly suspension given to healthy participants via 3 subcutaneous (SC) injections at Day 1.

Group Type: EXPERIMENTAL

exenatide once weekly

Intervention Type: DRUG

subcutaneous injection, 10.0 mg, single injection

Cohort 2: Diabetes Participants

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.

Group Type: EXPERIMENTAL

exenatide once weekly

Intervention Type: DRUG

subcutaneous injection, 2.0 mg, once a week for 12 weeks

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

subcutaneous injection, volume equivalent to Cohort 2 experimental intervention, once a week for 12 weeks

Interventions

exenatide once weekly

subcutaneous injection, 10.0 mg, single injection

Intervention Type: DRUG

exenatide once weekly

subcutaneous injection, 2.0 mg, once a week for 12 weeks

Intervention Type: DRUG

Placebo

subcutaneous injection, volume equivalent to Cohort 2 experimental intervention, once a week for 12 weeks

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vice President, Clinical Development

Role: STUDY_DIRECTOR

Amylin Pharmaceuticals, LLC.

Locations

Research Site

Lincoln, Nebraska, United States

Countries

United States

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3660&filename=Study_Synopsis.pdf

CSR\_Synopsis

Other Identifiers

BCB110

Identifier Type: -

Identifier Source: org_study_id