A study to examine the efficacy, safety and tolerability, and pharmacokinetics of exenatide once monthly suspension

Study identifier:BCB111

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomized, multi-dose, controlled trial investigating the efficacy, safety and tolerability, and pharmacokinetics of exenatide once monthly suspension.

Medical condition

Type 2 Diabetes

Phase

Phase 2

Healthy volunteers

Study drug

exenatide once weekly, exenatide once monthly suspension

Sex

All

Actual Enrollment

121

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 May 2010

Primary Completion Date: 01 Dec 2010

Study Completion Date: 01 Dec 2010

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2015 by AstraZeneca Pharmaceuticals

Collaborators

Eli Lilly and Company

Inclusion and exclusion 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

-Clinically significant medical condition that could potentially affect study participation including:
-Acute or chronic pancreatitis
-Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2
-Active cardiovascular disease within 3 months of study start
-Underlying hepatic or renal disease
-Inflammatory bowel disease, or other severe gastrointestinal diseases (particularly those that may affect gastric emptying, such as gastroparesis, pyloric stenosis, and metabolic surgery)
-Has had > 2 episodes of major hypoglycemia in the preceding 6 months before study start
- Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start
- 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

No locations available

Arms	Assigned Interventions
Active Comparator: 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 5 mg exenatide once monthly suspension SC.	Drug: exenatide once monthly suspension subcutaneous injection, low dose, once a month
Experimental: Group C Medium dose 8 mg exenatide once monthly suspension SC.	Drug: exenatide once monthly suspension subcutaneous injection, medium dose, once a month
Experimental: Group D High dose 11 mg exenatide once monthly suspension SC.	Drug: exenatide once monthly suspension subcutaneous injection, high dose, once a month

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center Telephone no (US and Outside the US):

1-877-240-9479

Investigators

Principal Investigator

Vice President Research and Development

Amylin Pharmaceuticals, Inc.