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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00894322
First received: May 5, 2009
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide once weekly
Other: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Cohort 1: To characterize the pharmacokinetics of a single dose of exenatide once weekly suspension in healthy subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Cohort 2: To examine the safety and tolerability of repeat-dose administration of exenatide once weekly suspension in subjects with type 2 diabetes mellitus [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Cohort 2: To characterize exenatide pharmacokinetics following repeat dose administration of exenatide once weekly suspension in subjects with type 2 diabetes mellitus [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cohort 1: To examine the safety and tolerability of a single dose of exenatide once weekly suspension in healthy subjects [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Cohort 2: To examine the effects of repeat-dose administration of exenatide once weekly suspension in subjects with type 2 diabetes mellitus on HbA1c, fasting plasma glucose concentration, and body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cohort 1
Drug: exenatide once weekly
subcutaneous injection, 10.0 mg, single injection
Experimental: 2
Cohort 2
Drug: exenatide once weekly
subcutaneous injection, 2.0 mg, once a week
Placebo Comparator: 3
Cohort 2
Other: Placebo
subcutaneous injection, volume equivalent to Cohort 2 experimental intervention, once a week

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894322

Locations
United States, Nebraska
Research Site
Lincoln, Nebraska, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Eli Lilly and Company
Investigators
Study Director: Vice President, Clinical Development Amylin Pharmaceuticals, LLC.
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00894322     History of Changes
Other Study ID Numbers: BCB110
Study First Received: May 5, 2009
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
diabetes
exenatide once weekly
Byetta
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014