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

This study is currently recruiting participants.

Verified by Amylin Pharmaceuticals, Inc., April 2009

First Received: April 6, 2009 Last Updated: April 7, 2009 History of Changes

Sponsors and Collaborators:	Amylin Pharmaceuticals, Inc. Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00877890

Purpose

This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: exenatide once weekly Drug: exenatide twice daily	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:

To compare the effect on glucose control, as measured by HbA1c, of exenatide once weekly to that of exenatide BID in subjects with type 2 diabetes mellitus [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the effects of exenatide once weekly in subjects with type 2 diabetes mellitus on fasting plasma glucose concentration and body weight [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
To examine the pharmacokinetics of exenatide once weekly in subjects with type 2 diabetes mellitus [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
To examine the safety and tolerability of exenatide once weekly in subjects with type 2 diabetes mellitus [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	244
Study Start Date:	March 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: exenatide once weekly subcutaneous injection, 2.0mg, once a week
2: Active Comparator	Drug: exenatide twice daily subcutaneous injection; 5mcg (4 weeks) and 10mcg (22 weeks); twice a day

Eligibility

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

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, an SU, a 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 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877890

Contacts

Contact: Amylin Call Center

800-349-8919

Show 41 Study Locations

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Amylin Pharmaceuticals, Inc. ( Lisa Porter, MD, Study Director )
Study ID Numbers:	BCB108 (DURATION-5)
Study First Received:	April 6, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00877890 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:

diabetes
exenatide once weekly
Byetta
Amylin
Lilly

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Exenatide
Amylin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009