A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)

Study identifier:BCB108 (DURATION-5)

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Open-Label, Parallel-Group, Comparator-Controlled, Multicenter Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 3

Healthy volunteers

Study drug

exenatide once weekly, exenatide twice daily

Sex

All

Actual Enrollment

254

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Mar 2009

Primary Completion Date: 01 Oct 2009

Study Completion Date: 01 Jan 2010

Study design

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

Verification:

Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

Inclusion Criteria

- Has been diagnosed with type 2 diabetes mellitus
- Has hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening
- Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening
- Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening
- 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 screening:
*Hormone replacement therapy (female subjects)
*Oral contraceptives (female subjects)
*Antihypertensive agents
*Lipid-lowering agents
*Thyroid replacement therapy
*Antidepressant agents
*Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over the counter antiobesity agents

Exclusion Criteria

- Has ever been exposed to exenatide (exenatide once weekly [exenatide LAR], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog
- Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening
- Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
*Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening
*Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening
*Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
*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

No locations available

Arms	Assigned Interventions
Experimental: 1	Drug: exenatide once weekly subcutaneous injection, 2.0mg, once a week Other Name: BYDUREON
Active Comparator: 2	Drug: exenatide twice daily subcutaneous injection; 5mcg (4 weeks) and 10mcg (20 weeks); twice a day Other Name: BYETTA

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center null

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Lisa Porter

Amylin Pharmaceuticals, Inc.