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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01104701
First received: April 13, 2010
Last updated: September 18, 2013
Last verified: September 2013

April 13, 2010
September 18, 2013
May 2010
December 2010   (final data collection date for primary outcome measure)
  • To examine the effect of exenatide once monthly suspension on glycemic control (HbA1c) in subjects with type 2 diabetes. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability (primary safety endpoint being incidence of treatment-emergent adverse events) of exenatide once monthly suspension in subjects with type 2 diabetes. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01104701 on ClinicalTrials.gov Archive Site
  • To examine the effect of exenatide once monthly suspension in subjects with type 2 diabetes on fasting plasma glucose. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • To examine the effect of exenatide once monthly suspension in subjects with type 2 diabetes on body weight. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • To assess the pharmacokinetics of exenatide once monthly suspension in subjects with type 2 diabetes. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension
A Randomized, Multi-dose, Controlled Trial Investigating the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension.

The purpose of Study BCB111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety, and tolerability data in patients with type 2 diabetes to assess the feasibility of once monthly dosing of the exenatide suspension formulation.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: exenatide once weekly
    subcutaneous injection, 2 mg, once a week
  • Drug: exenatide once monthly suspension
    subcutaneous injection, low dose, once a month
  • Drug: exenatide once monthly suspension
    subcutaneous injection, medium dose, once a month
  • Drug: exenatide once monthly suspension
    subcutaneous injection, high dose, once a month
  • Group A
    2 mg exenatide once weekly subcutaneous (SC). This arm is used as a reference arm in the study.
    Intervention: Drug: exenatide once weekly
  • Experimental: Group B
    Low dose exenatide once monthly suspension SC.
    Intervention: Drug: exenatide once monthly suspension
  • Experimental: Group C
    Medium dose exenatide once monthly suspension SC.
    Intervention: Drug: exenatide once monthly suspension
  • Experimental: Group D
    High dose exenatide once monthly suspension SC.
    Intervention: Drug: exenatide once monthly suspension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is at least 18 years old at study start
  • Has been diagnosed with type 2 diabetes mellitus
  • Has HbA1c of 7.1% to 11.0%, inclusive, at study start
  • Has been treated with diet and exercise alone or with a stable regimen of metformin, pioglitazone, or a combination of metformin and pioglitazone, 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); antihypertensive agents; thyroid replacement therapy; or antidepressant agents

Exclusion Criteria:

  • Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start
  • Has donated blood or had a significant blood loss within 2 months of first dosing of study medication or is planning to donate blood during the study
  • Has donated plasma within 7 days prior to first dose of study medication
  • Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:

    • Any exposure to exenatide (BYETTA®, exenatide once weekly, or exenatide suspension), liraglutide (Victoza®), or any GLP-1 receptor agonist
    • Any DPP-IV inhibitor, sulfonylurea (SU), or rosiglitazone (Avandia®) 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, intra-articular, 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
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01104701
BCB111
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Eli Lilly and Company
Study Director: Vice President Research and 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