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

May 5, 2009
September 18, 2013
April 2009
August 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00894322 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: exenatide once weekly
    subcutaneous injection, 10.0 mg, single injection
  • Drug: exenatide once weekly
    subcutaneous injection, 2.0 mg, once a week
  • Other: Placebo
    subcutaneous injection, volume equivalent to Cohort 2 experimental intervention, once a week
  • Experimental: 1
    Cohort 1
    Intervention: Drug: exenatide once weekly
  • Experimental: 2
    Cohort 2
    Intervention: Drug: exenatide once weekly
  • Placebo Comparator: 3
    Cohort 2
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
19 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00894322
BCB110
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Eli Lilly and Company
Study Director: Vice President, Clinical Development Amylin Pharmaceuticals, LLC.
Bristol-Myers Squibb
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP