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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: exenatide once weekly
Drug: exenatide once monthly suspension
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Multi-dose, Controlled Trial Investigating the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension.

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 121
Study Start Date: May 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
2 mg exenatide once weekly subcutaneous (SC). This arm is used as a reference arm in the study.
Drug: exenatide once weekly
subcutaneous injection, 2 mg, once a week
Experimental: Group B
Low dose exenatide once monthly suspension SC.
Drug: exenatide once monthly suspension
subcutaneous injection, low dose, once a month
Experimental: Group C
Medium dose exenatide once monthly suspension SC.
Drug: exenatide once monthly suspension
subcutaneous injection, medium dose, once a month
Experimental: Group D
High dose exenatide once monthly suspension SC.
Drug: exenatide once monthly suspension
subcutaneous injection, high dose, once a month

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104701

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

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01104701     History of Changes
Other Study ID Numbers: BCB111
Study First Received: April 13, 2010
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Exenatide
Amylin
Lilly
Byetta
Exenatide Once Weekly

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

ClinicalTrials.gov processed this record on April 16, 2014