Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1) - Full Text View

Sponsor:	Amylin Pharmaceuticals, Inc.
Collaborator:	Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00308139

Purpose

The purpose of this study is to examine the effects of exenatide long-acting release (LAR) on glucose control and safety in subjects with type 2 diabetes mellitus managed with diet modification and exercise and/or oral antidiabetic medications.

Condition	Intervention
Type 2 Diabetes Mellitus	Drug: exenatide, long acting release Drug: exenatide

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets Exercise and Physical Fitness

Drug Information available for: Exenatide

U.S. FDA Resources

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

Primary Outcome Measures:

To compare the effect on glucose control of exenatide LAR administered weekly by subcutaneous (SC) injection to that achieved by exenatide administered SC twice a day (BID) [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
To examine the safety and tolerability of exenatide LAR administered SC weekly [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
To examine glucose control during the transition from treatment with exenatide administered SC BID to exenatide LAR administered SC weekly [ Time Frame: transition period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the effects of exenatide LAR administered SC weekly on pharmacokinetics and various pharmacodynamic parameters [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
To examine the incidence and rate of hypoglycemic events associated with the proactive approach to sulphonylurea management [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
To examine the long-term safety and tolerability and effect on glucose control of exenatide LAR administered SC weekly [ Time Frame: open ended ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	March 2006
Estimated Study Completion Date:	September 2009
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: exenatide, long acting release subcutaneous injection, once a week
2: Active Comparator	Drug: exenatide subcutaneous injection, twice a day for the first 30 weeks, followed by exenatide LAR subcutaneous injection weekly for the remainder of the study

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Has type 2 diabetes mellitus treated with diet modification and exercise alone or in combination with a stable regimen of a combination of metformin, sulphonylureas, and thiazolidinediones for a minimum of 2 months at screening.
Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.

Exclusion Criteria:

Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any glucagon-like peptide-1 (GLP-1) analog.
Received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.
Has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:
- Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
- Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
- Regular use (> 14 days) of drugs that directly affect gastrointestinal motility;
- Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption;
- Regular use (> 14 days) of medications with addictive potential such as opiates and opioids;
- Prescription or over-the-counter weight loss medications within 6 months of screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308139

Show 26 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 by Amylin Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang D, Porter L; DURATION-1 Study Group. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008 Oct 4;372(9645):1240-50. Epub 2008 Sep 7.

Responsible Party:	Amylin Pharmaceuticals ( Lisa Porter, MD, Study Director )
Study ID Numbers:	2993LAR-105 (DURATION - 1)
Study First Received:	March 27, 2006
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00308139 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Amylin Pharmaceuticals, Inc.:

diabetes
exenatide
long acting release

LAR
Amylin
Lilly

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 November 05, 2009