A Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00477581
First received: May 21, 2007
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

This purpose of this study is to compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: exenatide
Drug: sitagliptin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Crossover Study to Compare the Effects of Exenatide and Sitagliptin on Postprandial Glucose in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To compare the effect of exenatide to that of sitagliptin on 2-hour postprandial glucose in subjects with type 2 diabetes mellitus [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the effect of exenatide to the effect of sitagliptin on various pharmacodynamic measurements in subjects with type 2 diabetes mellitus. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: May 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence A Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Other Name: Byetta
Drug: sitagliptin
oral administration (100mg), once a day in the morning
Other Name: Januvia
Experimental: Sequence B Drug: exenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Other Name: Byetta
Drug: sitagliptin
oral administration (100mg), once a day in the morning
Other Name: Januvia

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment with metformin for at least 2 months
  • Has HbA1c 7.0% to 11.0%, inclusive, at screening
  • Body mass index (BMI)25 kg/m^2 to 45 kg/m^2, inclusive
  • List of medications that are not allowed or the patient has been on stable treatment for at least 2 months:

    • Hormone replacement therapy (female subjects)
    • Oral contraceptives (female subjects)
    • Antihypertensive agents
    • Lipid-lowering agents
    • Thyroid replacement therapy

Exclusion Criteria

  • Has been treated with exenatide (BYETTA®) or any DPP-4 inhibitor prior to screening
  • Received any study medication or participated in any type of clinical trial within 30 days prior to screening
  • Has donated blood within 60 days of screening visit or is planning to donate blood during the study
  • Treated with any of the following medications:

    • Sulfonylurea or Thiazolidinedione within 3 months of screening;
    • Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®)within 30 days of screening;
    • Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 6 months of screening;
    • Drugs that directly affect gastrointestinal motility, including but not limited to, anticholinergics, macrolide antibiotics, dopamine antagonists, opioids, and Reglan®(metoclopramide);
    • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477581

Locations
United States, California
Research Site
Los Angeles, California, United States
Research Site
Spring Valley, California, United States
United States, Florida
Research Site
Miami, Florida, United States
Research Site
Pembroke Pines, Florida, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
Research Site
Indianapolis, Indiana, United States, 46260
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, Montana
Research Site
Butte, Montana, United States
United States, North Carolina
Research Site
Winston-Salem, North Carolina, United States
United States, Ohio
Research Site
Cincinatti, Ohio, United States
Research Site
Marion, Ohio, United States
United States, Oregon
Research Site
Eugene, Oregon, United States
Research Site
Portland, Oregon, United States
United States, South Carolina
Research Site
Charleston, South Carolina, United States
Research Site
Greer, South Carolina, United States
United States, Texas
Research Site
Austin, Texas, United States
Research Site
Corpus Christi, Texas, United States
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00477581     History of Changes
Other Study ID Numbers: BCA403
Study First Received: May 21, 2007
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by AstraZeneca:
diabetes
exenatide
sitagliptin
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Sitagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 15, 2014