A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension
This study has been completed.
Sponsor:
Amylin Pharmaceuticals, LLC.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01104701
First received: April 13, 2010
Last updated: March 6, 2013
Last verified: March 2013
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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 Amylin Pharmaceuticals, LLC.:
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
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
| Study Director: | Vice President Research and Development | Amylin Pharmaceuticals, LLC. |
More Information
No publications provided
| Responsible Party: | Amylin Pharmaceuticals, LLC. |
| ClinicalTrials.gov Identifier: | NCT01104701 History of Changes |
| Other Study ID Numbers: | BCB111 |
| Study First Received: | April 13, 2010 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
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 May 16, 2013