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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
Sponsors and Collaborators: Amylin Pharmaceuticals, Inc.
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

  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):
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

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 July 02, 2009