Full Text View
Tabular View
No Study Results Posted
Related Studies
Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)
This study is ongoing, but not recruiting participants.
First Received: March 27, 2006   Last Updated: September 30, 2008   History of Changes
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:


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

  Hide Study Locations
Locations
United States, California
Research Site
San Diego, California, United States
Research Site
La Jolla, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Encino, California, United States
United States, Colorado
Research Site
Colorado Springs, Colorado, United States
United States, Florida
Research Site
Miami, Florida, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
United States, Kentucky
Research Site
Lexington, Kentucky, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, Montana
Research Site
Butte, Montana, United States
United States, New York
Research Site
Rochester, New York, United States
United States, North Carolina
Research Site
Durham, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
Research Site
Marion, Ohio, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, South Carolina
Research Site
Greer, South Carolina, United States
United States, Texas
Research Site
San Antonio, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Midland, Texas, United States
United States, Washington
Research Site
Olympia, Washington, United States
Canada, Ontario
Research Site
Toronto, Ontario, Canada
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):
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 27, 2009